Textile mask systems

ABSTRACT

A mask system for providing pressurized breathable gas includes at least one panel and a seal member, wherein the panel comprises a textile. The panel defines a cavity adapted to receive a patient&#39;s nose. The seal member is adapted to sealingly engage with the patient&#39;s face. The panel and seal member may be integrally formed in one piece.

CROSS-REFERENCE TO APPLICATION

This application claims the benefit of U.S. Provisional Application No.61/457,935, filed Jul. 12, 2011, which is incorporated herein byreference in its entirety.

FIELD OF THE TECHNOLOGY

The present technology relates to a nasal mask system used fortreatment, e.g., of Sleep Disordered Breathing (SDB) with ContinuousPositive Airway Pressure (CPAP) or Non-Invasive Positive PressureVentilation (NIPPV).

BACKGROUND OF THE TECHNOLOGY

Patient interfaces, such as a full-face or nasal mask systems, for usewith blowers and flow generators in the treatment of Sleep DisorderedBreathing (SDB), including sleep apnea, typically include a softface-contacting portion, such as a cushion, and a rigid or semi-rigidshell or frame. In use, the interface is held in a sealing position byheadgear so as to enable a supply of air at positive pressure (e.g.,2-30 cm H₂O) to be delivered to the patient's airways.

One factor in the efficacy of therapy and compliance of patients withtherapy is the comfort and fit of the patient interface.

The present technology provides alternative arrangements of mask systemsto enhance the efficacy of therapy and compliance of patients withtherapy.

SUMMARY OF TECHNOLOGY

One aspect of the present technology relates to a mask constructed of atextile.

Another aspect of the present technology relates to a mask constructedof a textile composite and a seal member. The seal member may beconstructed of a polymer.

Another aspect of the present technology relates to a mask constructedof a textile composite and a seal member. The seal member may beconstructed of a polymer, wherein the polymer is tacky.

Another aspect of the present technology relates to a mask constructedof a first textile composite and a second textile composite.

Another aspect of the present technology relates to a mask constructedof a first textile composite and a second textile composite. The firsttextile composite and second textile composite are sealingly engaged.

Another aspect of the present technology relates to a mask constructedof a first textile composite and a second textile composite. The firsttextile composite and second textile composite are sealingly engagedalong a perimeter surface using a welding process. The welding processmay be radiofrequency or ultrasonic welding.

Another aspect of the present technology relates to a mask constructedof a first textile composite and a second textile composite, and thefirst textile composite and second textile composite are sealinglyengaged along a perimeter surface using a radiofrequency weld orultrasonic weld. The perimeter surface may be arranged in a threedimensional form.

Another aspect of the present technology relates to a mask constructedof a textile arranged in a dome shape.

Another aspect of the present technology relates to a mask constructedof a textile arranged in a positive Gaussian curvature.

Another aspect of the present technology relates to a mask constructedof a textile, the textile having a curvature, the curvaturesubstantially defined by a rigidized frame.

Another aspect of the present technology relates to a mask constructedof a textile, the textile may be crushable or deformable under forceapplied by a human hand or finger pressure.

Another aspect of the present technology relates to a mask constructedof a wall, the wall not able to support its own weight. The wall may besubstantially floppy. The wall may be substantially non-resilient. Thewall may be formed of a textile. The wall may have a hand of one or moreof the following terms: drapable, rough, fibrous, coarse, silky, soft,flexible, warm, non-clammy. The wall may be a material having the feelof a textile. The wall may be opaque, or substantially non-translucent.

Another aspect of the present technology relates to a mask including awall, the wall not able to support its own weight. The wall may beformed of a textile. The wall may be attached to a sealing portion,preferably the sealing portion supports the wall. The sealing portionmay be formed of a polymer such as silicone.

Another aspect of the present technology relates to a mask including asubstantially non-rigid, substantially non-resilient wall, the wallconstructed of a textile. In use, the wall is preferably shaped toaccommodate a patient's face by one or a combination of activation ofpositive pressure, darts in the wall, resilient seal structure,rigidized frame.

Another aspect of the present technology relates to a mask having asubstantially inextensible, substantially non-resilient textile wall.The textile wall may be connected to a resilient seal member.

Another aspect of the present technology relates to a mask having acombination of at least one semi-rigid, flexible and/or resilientsupport member, and a substantially inextensible, substantiallynon-resilient textile wall. In use the support member allows the maskstructure to unfold, e.g. from a first folded state to a second unfoldedstate. Preferably, the mask may also include at least one substantiallyrigid connection member adapted to receive an air delivery conduit.Preferably, the at least one substantially rigid connection member mayinclude a vent.

Another aspect of the present technology relates to a mask including awall or shell, the wall or shell constructed and arranged to have apredefined shape, the wall or shell being made from a non-rigid element;and a support beam adapted to conform to the patient's upper lip region,the support beam adapted to support its own weight, the support beam mayalso be substantially inextensible.

Another aspect of the present technology relates to a mask including atextile shell, the textile shell connected to or otherwise formed with arigidizer, the rigidizer having a length that is greater than its widthand/or thickness. Preferably the rigidizer is positioned over thepatient's upper lip. Preferably, the rigidizer is not positioned overthe patient's nasal bridge. Preferably, the rigidizer anchors and/orpositions other rigid elements with respect to one another, e.g., one ormore cuffs, a vent portion, an annular elbow connection.

Another aspect of the present technology relates to a mask constructedof a first textile composite and a second textile composite, and thefirst textile composite and second textile composite are sealinglyengaged along a perimeter surface. The first and second textilecomposite may form a cavity.

Another aspect of the present technology relates to a mask constructedof a textile composite. The textile composite may comprise a fabric anda polymer.

Another aspect of the present technology relates to a mask constructedof a combination of textile and polymer. The mask may comprise a chamberforming portion including a seal member. The chamber forming portion maybe comprised of a composite textile comprising a fabric and a polymer.The seal member may be comprised of a polymer. The polymer may be a lowhardness polymer such as a silicone having a Shore A hardness of 5-20.

Another aspect of the present technology relates to a mask constructedof a textile composite. The mask may further comprise a one or morecuffs. The cuff(s) may be arranged to receive a supply of breathable gasfrom an air delivery tube. The cuff(s) may be adapted to sealinglyengage with the textile. The cuff(s) may also be removably attachable.Further, the cuff(s) may be welded to the textile. The cuff(s) may besealable by placing a plug in the cuff. The cuff(s) may include maleand/or female connectors. The cuff(s) may include a venting portionadapted to vent expired exhaust gases. For example, one cuff may receiveincoming air and another cuff may exhaust expired gases.

Another aspect of the present technology relates to a mask system fordelivering pressurized breathable gas to a patient. The mask systemcomprises a chamber forming portion including 1) at least one panel atleast partially delimiting a cavity adapted to receive a nose of apatient, the at least one panel including a first panel having anopening formed therein through which the patient's nose is received intothe cavity; and 2) a seal member formed as part of or coupled to thefirst panel and adapted to sealingly engage the patient's face, whereinthe first panel comprises a textile and the seal member comprises apolymer.

Another aspect of the present technology relates to a mask system fordelivering pressurized breathable gas to a patient. The mask systemcomprises a chamber forming portion including a back panel at leastpartially delimiting a cavity adapted to receive a patient's nose, theback panel including an upper panel coupled to a lower panel such thatan opening is formed between the upper panel and the lower panel, theopening configured such that the patient's nose is received into thecavity through the opening, wherein the upper panel has an upper sealportion configured to seal against the patient's external nares, and thelower portion has a lower seal portion configured to seal against thepatient's upper lip.

Another aspect of the present technology relates to a tube managementsystem for reducing drag on a tube arranged to deliver breathable gas toa chamber forming portion positioned on a patient's face in sealingengagement therewith. The tube management system comprises headgear tosupport the chamber forming portion on the patient's face, the headgearincluding an anchor member provided towards a rear of the patient's head(e.g., below the occiput, adjacent the nape, or below the ear) andconfigured to receive the tube to reduce or prevent disruptive forcesexerted on the chamber forming portion by the tube.

Another aspect of the present technology relates to a headgear forsupporting a patient interface (e.g., a mask) on a patient's face, thepatient interface arranged to be positioned adjacent the patient's nosein sealing communication with at least one of the patient's airways. Theheadgear consists essentially of a single strap coupled to the mask andextending from a first portion of the mask to a second portion of themask.

Another aspect of the present technology relates to a mask for use inrespiratory therapy. The mask comprises a seal adapted to surround andsealingly engage a patient's airway; a cushion adapted to support theseal; and an enclosing portion adapted to form a chamber with the sealand the cushion, wherein the seal is adapted to stretch over thepatient's nose bridge, and the enclosing portion is formed of a textile.

Another aspect of the present technology relates to a mask for arespiratory device. The mask comprises a seal forming portion adapted tostretch over the patient's nose bridge; a cushion portion constructedand arranged to match the contours of the patient's face; and a chamberforming portion constructed of a textile and adapted to flex around thepatient's face.

Another aspect of the present technology relates to a mask for use intreating sleep disordered breathing. The mask comprises a chamberconstructed from a textile; a cuff adapted to connect with an airdelivery tube; and a rigid element adapted to support the chamber inposition on the patient's face, the rigid element formed integrally withthe cuff (e.g., in one piece).

Another aspect of the present technology relates to a mask adapted foruse in the treatment of sleep disordered breathing. The mask comprises achamber constructed of a textile, wherein the textile includes dartsconstructed and arranged to shape the textile in a three dimensionalform.

Another aspect of the present technology relates to a mask adapted foruse in the treatment of sleep apnea. The mask comprises a chamberforming structure constructed of a textile; a support beam; at least onecuff; and a vent, wherein the support beam, the at least one cuff andthe vent are formed in one piece.

Other aspects, features, and advantages of the present technology willbecome apparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thistechnology.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of the technology. In such drawings:

FIG. 1-1 is a side view of a nasal mask system positioned on a patient'sface according to an example of the disclosed technology;

FIG. 1-2 is a side view of the nasal mask system of FIG. 1 removed fromthe patient's face;

FIG. 1-3 is a first perspective view of the nasal mask system of FIG.1-2;

FIG. 1-4 is a second perspective view of the nasal mask system of FIG.1-2;

FIG. 1-5 is a rear view of the nasal mask system of FIG. 1-2;

FIG. 1-6 is a front view of the nasal mask system of FIG. 1-2;

FIG. 1-7 is a top view of the nasal mask system of FIG. 1-2;

FIG. 1-8 is a bottom view of the nasal mask system of FIG. 1-2;

FIG. 1-9 is a first exploded perspective view of the nasal mask systemof FIG. 1-2;

FIG. 1-10 is a second exploded perspective view of the nasal mask systemof FIG. 1-2;

FIG. 1-11 is a cross-sectional view along the line 1-11-1-11 in FIG.1-5;

FIG. 1-12 is a perspective view of the cross-section along the line1-12-1-12 in FIG. 1-5;

FIG. 1-13 is a side view of a cross-section along a line similar to theline 1-12-1-12 in FIG. 1-5;

FIG. 2-1 is a front view of a back panel and a sealing member positionedon a patient's face in accordance with an example of the disclosedtechnology;

FIG. 2-2 is a perspective view of the back panel and sealing member ofFIG. 2-1;

FIG. 3-1 is a vertical cross-section of a mask according to an exampleof the disclosed technology;

FIG. 3-1A is a horizontal cross-section of the mask of FIG. 3-1 shownpositioned on a patient's face according to an example of the disclosedtechnology;

FIG. 3-2 is a horizontal cross-section of a mask positioned on apatient's face according to an example of the disclosed technology;

FIG. 4-1 is a vertical cross-section of a mask according to an exampleof the disclosed technology;

FIG. 4-1A is a horizontal cross-section of the mask of FIG. 4-1 shownpositioned on a patient's face according to an example of the disclosedtechnology;

FIG. 5-1 is a perspective view of a mask having a raised sectionaccording to an, example of the disclosed technology;

FIG. 5-2 is a perspective view of a portion of the mask of FIG. 5-1;

FIG. 5-2A shows the mask portion of FIG. 5-2 positioned on a patient'sface in accordance with an example of the disclosed technology;

FIG. 5-3 is a schematic representation showing a partial cross-sectionof a mask being positioned on a patient's face in accordance with anexample of the disclosed technology;

FIG. 5-4 is a horizontal cross-section of a mask positioned on apatient's face according to an example of the disclosed technology;

FIG. 5-5 is a partial cross-sectional view of a mask showing paddingconnected to the mask according to an example of the disclosedtechnology;

FIG. 5-6 is a partial cross-sectional view of a mask showing paddingconnected to the mask according to an example of the disclosedtechnology;

FIG. 5-7 is a partial cross-sectional view of a mask showing paddingconnected to the mask according to an example of the disclosedtechnology;

FIG. 5-8A is a perspective view of a mask including padding according toan example of the disclosed technology;

FIG. 5-8B is a top view of the mask of FIG. 5-8A;

FIG. 5-8C is a cross-sectional view of the mask of FIG. 5-8A positionedon a patient having a relatively shallow nose bridge height inaccordance with an example of the disclosed technology;

FIG. 5-8D is a cross-sectional view of the mask of FIG. 5-8A positionedon a patient having a relatively larger nose bridge height in accordancewith an example of the disclosed technology;

FIG. 6-1 is a vertical cross-section of a mask including a rigidizingelement according to an example of the disclosed technology;

FIG. 7-1 is a front view of a portion of a mask including a rigidizingelement according to an example of the disclosed technology;

FIG. 7-2 is a perspective view of a portion of a mask including arigidizing element according to an example of the disclosed technology;

FIG. 7-3 is a perspective view of a portion of a mask including arigidizing element being positioned on a patient's face according to anexample of the disclosed technology;

FIG. 8-1 is a horizontal cross-section of a mask including a rigidizingelement positioned on a patient's face according to an example of thedisclosed technology;

FIG. 8-2 is a horizontal cross-section of a mask including a rigidizingelement positioned on a patient's face according to an example of thedisclosed technology;

FIG. 9 is a schematic representation of a mask positioned on a patienthaving a relatively narrower nose and on a patient having a relativelywider nose;

FIG. 10-1 is a perspective view of a mask system having a multi-layerseal member according to an example of the disclosed technology;

FIG. 10-2 is an exploded perspective view of a multi-layer seal memberaccording to an example of the disclosed technology;

FIG. 11-1 shows a base layer of the seal member positioned on apatient's face according to an example of the disclosed technology;

FIG. 11-2 is a front view of the base layer of FIG. 11-1;

FIG. 11-3 is a front view showing the base layer of FIG. 11-1 beingpulled into position on the patient's face according to an example ofthe disclosed technology;

FIG. 11-4 is a side view showing the base layer of FIG. 11-1 beingpulled into position on the patient's face according to an example ofthe disclosed technology;

FIG. 12-1 is a front view showing the base layer and a cushioning layerof the seal member according to an example of the disclosed technology;

FIG. 12-2 shows the base layer and the cushioning layer of FIG. 12-1positioned on a patient's face according to an example of the disclosedtechnology;

FIG. 12-3 is a schematic representation of a cushion including a sealmember without the cushioning layer positioned on a patient's faceaccording to an example of the disclosed technology;

FIG. 12-4 is a schematic representation of a cushion including a sealmember having the cushioning layer positioned on a patient's faceaccording to an example of the disclosed technology;

FIG. 13-1 is a front view showing the base layer, the cushioning layerand an interfacing layer of a seal member according to an example of thedisclosed technology;

FIG. 13-2 is a front view of the interfacing layer of FIG. 13-1;

FIG. 13-3 is a front view showing the base layer, the cushioning layerand the interfacing layer of FIG. 13-1 being pulled into position on thepatient's face according to an example of the disclosed technology;

FIG. 13-4 is a side view showing the base layer, the cushioning layerand the interfacing layer of FIG. 13-1 being pulled into position on thepatient's face according to an example of the disclosed technology;

FIG. 14 shows the layers of a seal member according to an example of thedisclosed technology;

FIG. 15-1 is a perspective view of a mask system according to an exampleof the disclosed technology;

FIG. 15-2 shows the mask system of FIG. 15-1 being positioned on apatient's face according to an example of the disclosed technology;

FIG. 15-3 is a front view of an upper panel and a lower panel of themask system of FIG. 15-1;

FIG. 15-4 is a front view of the upper panel of FIG. 15-3;

FIG. 15-5 is a schematic representation of the upper panel positioned ona patient's face according to an example of the disclosed technology;

FIG. 15-6 is a schematic representation of the lower panel positioned ona patient's face according to an example of the disclosed technology;

FIG. 15-7 is a front view showing the upper panel and the lower panel ofFIG. 15-1 being pulled into position on the patient's face according toan example of the disclosed technology;

FIG. 16-1 is an exploded view of a mask system according to an exampleof the disclosed technology;

FIG. 16-1 is an exploded perspective view of a mask system according toan example of the disclosed technology;

FIG. 16-3 is a perspective view of a mask system according to an exampleof the disclosed technology;

FIG. 16-4 is a cross-sectional view along the line 16-4-16-4 of FIG.16-3;

FIG. 16-5 is a cross-sectional view along the line 16-5-16-5 of FIG.16-3;

FIG. 17-1 is a perspective view of a mask according to an example of thedisclose technology;

FIG. 17-2 is a cross-section of the mask of FIG. 17-1;

FIG. 17-3 is a rear perspective view of the mask of FIG. 17-1;

FIG. 17-4 is a side view of the mask of FIG. 17-1 positioned on apatient's face according to an example of the disclosed technology;

FIG. 17-5 is a front view showing mask sections before assemblyaccording to an example of the disclosed technology;

FIG. 18-1 is a perspective view of a mask system according to an exampleof the disclose technology;

FIG. 18-2 is a perspective view of a mask system according to an exampleof the disclose technology;

FIG. 18-3 is a cross-sectional view along the line 18-3-18-3 of FIG.18-2;

FIG. 18-4A is a front perspective view of headgear positioned on apatient's head according to an example of the disclosed technology;

FIG. 18-4B is a side perspective view of the headgear of FIG. 18-4A;

FIG. 18-5 is a perspective view of a mask system according to an exampleof the disclose technology;

FIGS. 18-6A to 18-6D are perspective views of headgear according toexamples of the disclosed technology;

FIG. 18-6E is an enlarged front view of the headgear fastening member ofFIG. 18-6D.

FIG. 19-1 is a perspective view of a mask system according to an exampleof the disclose technology;

FIGS. 19-2 and 19-3 are front views of a partial mask system positionedon a patient's face according to an example of the disclosed technology;

FIGS. 19-4 and 19-5 are side views of a partial mask system positionedon a patient's face according to an example of the disclosed technology;

FIG. 20 is a perspective view of a mask system according to an exampleof the disclose technology;

FIGS. 21-1A to 21-2 show an air delivery tube according to an example ofthe disclosed technology;

FIG. 21-3A is a front view of an air delivery tube according to anexample of the disclosed technology;

FIG. 21-3B is an enlarged detail of a connection before an air deliverytube and a mask according to an example of the disclosed technology;

FIG. 21-4 is a cross-section of an air delivery tube according to anexample of the disclosed technology;

FIGS. 21-5A to 21-5D show a process of making an air delivery tubeaccording to an example of the disclosed technology;

FIG. 21-6A is a perspective view of an air delivery tube according to anexample of the disclosed technology;

FIG. 21-6B is an end view of the air delivery tube of FIG. 21-6A;

FIG. 21-6C is a perspective view of the support structure of FIG. 21-6A;

FIG. 21-7A is a front view of a tube sheet according to an example ofthe disclosed technology;

FIG. 21-7B is a perspective view showing the tube sheet of FIG. 21-7Abeing formed into a tube according to an example of the disclosedtechnology;

FIG. 21-8A is a top view of a support structure according to an exampleof the disclosed technology;

FIG. 21-8B is an end view of an air delivery tube including the supportstructure of FIG. 21-8A according to an example of the disclosedtechnology;

FIG. 21-9 is a perspective view of a support structure according to anexample of the disclosed technology;

FIG. 21-10 is a perspective view of a support structure according to anexample of the disclosed technology;

FIG. 21-11 is a perspective view of a support structure according to anexample of the disclosed technology;

FIG. 21-12A is a perspective view of a support structure according to anexample of the disclosed technology;

FIG. 21-12B is a top view of the support structure of FIG. 21-12A; and

FIG. 21-13 is a perspective view of a support structure according to anexample of the disclosed technology.

DETAILED DESCRIPTION OF ILLUSTRATED EXAMPLES

The following description is provided in relation to several examples(most of which are illustrated, some of which may not) which may sharecommon characteristics and features. It is to be understood that one ormore features of any one example may be combinable with one or morefeatures of the other examples. In addition, any single feature orcombination of features in any of the examples may constitute additionalexamples.

In this specification, the word “comprising” is to be understood in its“open” sense, that is, in the sense of “including”, and thus not limitedto its “closed” sense, that is the sense of “consisting only of”. Acorresponding meaning is to be attributed to the corresponding words“comprise”, “comprised” and “comprises” where they appear.

The term “air” will be taken to include breathable gases, for exampleair with supplemental oxygen. The respiratory therapy devices or blowersdescribed herein may be designed to pump fluids other than air.

One or more examples may include exemplary dimensions. Although specificdimensions and ranges may be provided, it is to be understood that thesedimensions and ranges are merely exemplary and other dimensions andranges are possible depending on application. For example, ranges thatvary from those provided +/−10% may be suitable for particularapplications.

In this specification, any reference to the term ‘resilience’ is definedto mean a material that is able to spring back or return to its originalshape after deformation. The time for the material to return or springback may be less than approximately 1 second.

In this specification, the handle or hand is defined to mean the qualityof a fabric or yarn assessed by the reaction obtained from the sense oftouch, it is concerned with the judgment of roughness, smoothness,harshness, pliability, thickness, etc.

Substantially rigid is taken to mean not readily deforming to fingerpressure. Substantially non-rigid is taken to mean readily deforming tofinger pressure.

1.0 Mask System

Examples of the disclosed technology are directed towards a mask system(for example, a nasal mask system) that is unobtrusive, comfortable,visually appealing, easy to fit, manufacturable in high volumes,provides an effective seal with the patient and/or fits a large majorityof the population. While each example below is described as including anasal type interface, aspects of the technblogy may be adapted for usewith other suitable interface types, e.g. full face, oro-nasal, mouth,pillows, prongs, etc.

In accordance with an example of the disclosed technology shown in FIGS.1-1 to 1-13, the mask system includes a patient interface (e.g., mask10) adapted td engage a patient's face to seal therewith and deliverbreathable gas to the patient's airways. The patient interface may forma chamber, pocket or enclosing portion adapted to deliver gases from arespiratory device to a patient's airways. As shown in FIG. 1-2, themask 10 includes a patient contacting side 12 and a non-patientcontacting side 14. As best shown in FIGS. 1-10 to 1-12, a back panel 20and a front panel 30 are joined to form a cavity 16 which receives thepatient's nose. A seal member 40 is attached to the back panel 20 andengages the patient's face to form a seal therewith.

Each side of the mask 10 may be coupled to a cuff 50. The cuffs 50 areconfigured to be coupled to an air delivery tube to receive a supply ofbreathable, pressurized gas from the air delivery tube. It will beappreciated that the mask may be coupled to only one cuff. The cuff(s)may be sealed, if required, by a plug or seal device. The mask ispreferably held on the patient's face by headgear.

The back panel 20 may be constructed and arranged to be positioned nearor proximal to a patient's face. The back panel 20 has a generallytriangular or trapezoidal shape. Although, alternative shapes may bepossible, for example elliptical, circular, square etc. Preferably, theback panel 20 is shaped to provide a visual cue to the patient as to theorientation of the mask. For example, a triangular shape tends toindicate to the patient that the apex of the back panel 20 is to bepositioned at the nasal bridge region and that the sides of the backpanel are to be positioned along the patient's cheeks or sides of thenose.

The back panel 20 may have a generally concave shape across thepatient's face (from left to right sides of the nose). Suchconfiguration may more readily seal with a patient's face as it isanatomically matched to the shape of a human face.

The back panel 20 includes a main body 21, an upper flange 22 along anupper perimeter of the main body and a lower flange 24 along a lowerperimeter of the main body. The upper flange 22 includes an upperengaging surface 23 and the lower flange 24 includes a lower engagingsurface 25. The upper engaging surface 23 and the lower engaging surface25 sealingly engage and are coupled to corresponding surfaces of thefront panel 30 to form the mask 10, as will be described later. Anopening 26 is formed in the main body 21 of the back panel 20 and isconfigured to receive the patient's nose and permit passage ofbreathable gas to the patient's airways. The opening 26 may have agenerally triangular shape, or any other suitable configuration.

The main body 21 of the back panel 20 preferably has a curvature fromthe upper flange 22 to the lower flange 24, as shown in FIGS. 1-9 and1-10. Such curvature, together with the front panel 30, creates a spacewhich forms the cavity 16. A left side portion and a right side portionof the main body may include cuff connecting surfaces 28 and 38 whichsealingly engage the cuffs 50. The main body 21 of the back panel 20includes an engagement portion 21-1 which sealingly engages the sealmember 40, as shown in FIGS. 1-11 and 1-13.

In an alternative arrangement, the main body 21 of the back panel 20 maybe substantially flat or planar and may flex or conform to the curvatureof the patient's face.

As best shown in FIG. 1-10, the upper flange 22 may be angled to form acentral apex that is adapted to conform to the nasal bridge region ofthe patient's face. The lower flange 24 may be shaped to conform to thepatient's top lip and lower portion of the nose. For example, as bestshown on FIG. 1-9, the lower flange 24 may comprise at least two curvesor undulations 27 having a central portion 29 forming a lower extent ofthe undulations 27. The central portion 29 may form a convex curvatureadapted to accommodate the patient's septum or philtrum region.

The back panel 20 may be constructed of a textile. Such textile may bean air holding or sealed textile that may not permit gases to passthrough its fibers. For example, the textile may be a composite materialhaving a first layer of fabric and a second layer of polymer (i.e., acoated textile). The second layer of polymer may be a film, spray coator other arrangement adapted to seal the first layer.

Preferably the fabric is soft and conformable as the back panel 20 maycontact the patient's face. Accordingly, the fabric may be a softtextile, for example cotton, satin, micro fleece, nylon, polar fleece,velvet, corduroy, etc. Bedroom friendly materials on the outer surfaceshelp with patient compliance as these materials increase the comfort anddesirability of the mask. This also gives the mask a non-medicalappearance which may be more appealing to patients. The polymer may be,for example, polyurethane, polyester, silicone, nylon, etc.

In an example, the back panel 20 has a height (for example from centralportion 29 to the apex of the upper flange 22) of about 45-80 mm (e.g.,50-70 mm, or about 60 mm, or about 65 mm).

In an example, the back panel 20 may have a width (for example from oneend of the lower flange 24 to the other end of the lower flange) ofabout 80-120 mm (e.g., 90-110 mm, or about 100 mm, or about 96 mm).

In an example, the opening 26 has a height of about 20-50 mm (e.g.,35-60 mm, or about 35 mm, or about 40 mm).

In an example, the opening has a width of about 20-50 mm (e.g., 25-45mm, or about 35 mm).

The front panel 30 is positioned on the non-patient contacting side ofthe mask 10. The front panel 30 generally forms a triangular ortrapezoidal shape, although other suitable shapes such as elliptical,circular, square, etc may be used. Preferably, the front panel 30 has ashape similar to the shape of the back panel 20.

As best shown in FIGS. 1-9 and 1-10, the front panel 30 includes a mainbody 31, an upper flange 32 along an upper perimeter of the main bodyand a lower flange 34 along a lower perimeter of the main body. Theupper flange 32 includes an upper engaging surface 33 and the lowerflange 34 includes a lower engaging surface 35. The upper engagingsurface 33 and the lower engaging surface 35 sealingly engage and arecoupled to the upper and lower engaging surfaces 23, 25 of the backpanel 20 to form the mask 10.

The main body 31 of the front panel 30 preferably has a curvature fromthe upper flange 32 to the lower flange 34, as shown in FIGS. 1-1, 1-10and 1-11. The curvature helps create the space which forms the cavity 16to accommodate the patient's nose. Side portions of the main body 31 mayinclude cuff connecting surfaces 38 which sealingly engage the cuffs 50.

As best shown in FIG. 1-6, the upper flange 32 may be angled to form acentral apex to conform to the nasal bridge region of the patient'sface. The lower flange 34 may be shaped to conform to the patient's toplip and lower portion of the nose. For example, as best shown on FIG.1-9, the lower flange 34 may comprise at least two curves or undulations37 having a central portion 39 forming a lower extent of the undulations37. The central portion 39 may form a convex curvature adapted toaccommodate the patient's septum or philtrum region.

The front panel 30 may be constructed of a textile. The textile may bean air holding or sealed textile that may not permit gases to passthrough its fibers. For example, the textile may be a composite materialhaving a first layer of fabric and a second layer of polymer (i.e. acoated textile). The second layer of polymer may be a film, spray coator other arrangement adapted to seal the first layer. In an alternativeform, the front panel 30 may be constructed or formed from a clear orgenerally clear material including for example polycarbonate,polypropylene, or silicone, so that the patient's nose may be visible toa clinician.

The front panel 30 may include a vent portion. For example, a ventcomponent (such as a grommet or insertable vent component) may besealingly attached to front panel 30. The vent component may besubstantially rigid or semi-rigid in order to maintain the patency ofthe vent holes and reduce vent noise. Alternatively, the fabric of thefront panel 30 may be selectively sealed such that a portion of thefabric is not air tight, thereby acting as a vent.

In use, a seal member (e.g., a flap seal, in this example, made fromtextile and/or an elastomer) of thin material may have a self sealingaction when positive air pressure is applied within the mask, which maystiffen the textile of the front panel 30, thereby creating a largerspace to accommodate the patient's nose.

In an example, the front panel has a height of about 45-80 mm (e.g.,50-70 mm, or about 60 mm, or about 65 mm).

In an example, the front panel 30 has a width (for example from one endof the lower flange 34 to the other end of the lower flange) of about80-120 mm (e.g., 90-110 mm, or about 100 mm, or about 96 mm).

In an example, the front panel 30 has a radius of curvature a, as shownin FIG. 1-2, along the vertical axis of about 10-30 mm (e.g., 10-25 mm,or about 15 mm).

In an example, the front panel 30 has a radius of curvature α, as shownin FIG. 1-7, along the horizontal axis of about 10-30 mm (e.g., 10-25mm, or about 15 mm).

Preferably, the fabric is visually appealing since the front panel 30 ismost visible when the mask is in use. The fabric may be a soft textilewithout being visually bulky, for example nylon, cotton, linen, dazzle,silk etc. The polymer may be polyurethane, polyester, silicone, nylonetc.

The back panel 20 and the front panel 30 may be integrally formed. Theback panel 20 and the front panel 30 may be sealingly engaged bywelding, heat pressing, or other methods. Alternatively, the back panel20 and the front panel 30 may be sealingly engaged by stitching or othersuitable methods.

In an example, the upper flange 22 of the back panel 20 and upper flange32 of the front panel 30 may be aligned. Likewise, the lower flange 24of the back panel 20 and lower flange 34 of the front panel 30 are alsoaligned. The upper engaging surfaces 23, 33 of the back panel 20 and thefront panel 30, as well as the lower engaging surfaces 25, 35 may bewelded using radiofrequency or ultrasonic welding. A radiofrequency weldmay create a more robust seal which may be preferable in creating an airtight cavity. Preferably, the weld may be three dimensional so as toensure the shape of the mask 10 is three dimensional. In a furtherexample, a radiofrequency weld may first be formed and a subsequentultrasonic cut may be made. The ultrasonic cut may round or otherwisecurve the edge of the textile in order to prevent facial marking andthereby increase patient comfort.

In an example, the upper and lower engaging surfaces 23, 25 of the backpanel 20 and the upper and lower engaging surfaces 33, 35 of the frontpanel 30 have a width of about 1-10 mm (e.g., 2-6 mm).

Headgear may be attached or otherwise connected to the mask.Alternatively, headgear may be formed with or as a part of the frontpanel 30 and/or the back panel 20.

A rigidizer (or stiffening element) may be formed with or attached tothe front panel 30 and/or the back panel 20. The rigidizer may providestructural stability and support for the mask 10. For example, therigidizer may be a semi-rigid or a rigid component, such as a polymershaft or frame. The rigidizer may be positioned at the nasal bridgeregion (so as to ensure seal at the nasal bridge region and/or sides ofthe patient's nose adjacent the nasal bridge region of the patient'sface as the curvature of the face in this region is particularlydifficult to seal against), the top lip region of the patient's faceand/or the corners of the nose, for example. Furthermore, the rigidizermay interconnect the cuffs 50.

The seal member 40, as best shown in FIGS. 1-5 and 1-10, is adapted tosealingly engage with the patient's face. The seal member 40 includes amain body 41 and an opening 46 formed in the main body. The main body 41includes an connecting portion 41-1 that sealingly engages or isotherwise attached to the engagement portion 21-1 of the back panel 20.

The seal member 40 may be constructed and arranged to be positionedproximal to and in sealing engagement with a patient's airways. The sealmember 40 may have a generally triangular or trapezoidal shape.Alternative shapes may be possible, (e.g., elliptical, circular, square,etc.). Preferably, the seal member 40 is shaped to provide a visual cueto the patient as to the orientation of the mask. For example, atriangular shape tends to indicate to the patient that the apex of theseal member 40 is to be positioned near the nasal bridge region.

The opening 46 formed in the main body 41 of the seal member may have atriangular or tri-lobular shape, although other suitable shapes may beused.

The seal member 40 may be constructed of a polymer. Preferably, thepolymer may have a low hardness so as to readily adapt and conform tothe shape of the patient's face. For example, the polymer may besilicone, thermoplastic elastomer, polyurethane, etc., having a Type Aor Shore A hardness of 5-20 and a thickness of about 0.3-2 mm (e.g., aShore A hardness of 5-10 and a thickness of 0.3-2 mm). The polymer maybe a low durometer e.g. Type 00 or Shore 00 hardness of 20-40.

In a further alternative, the seal member 40 may be constructed of atacky or sticky material to better grip the patient's face and therebyform a more robust seal. Tackiness may be provided through surfacefinish, application of an adhesive or by virtue of the materialsproperties (e.g. low durometer silicone, e.g. silicone with a Type 00 orShore 00 hardness of 5-20 is inherently tacky).

In a further alternative, the seal member 40 may be constructed of atextile. Alternatively, the seal member 40 may be constructed of acombination of materials such as a tacky material and a textile.

As mentioned above, the seal member 40 sealingly engages the back panel20. The seal member 40 may be thermoformed, overmolded, glued, welded orotherwise connected to the back panel 20. Preferably, the connectingportion 41-1 of the seal member 40 and the engagement portion 21-1 ofthe back panel 20 overlap to ensure that the seal member 40 and the backpanel 20 are sealingly engaged, so as to prevent a leak path. In anexample, the overlap may be about 1-10 mm wide (e.g., 2-6 mm).

In an example, the seal member 40 has a height of about 30-60 mm (e.g.,40-60 mm, or about 55 mm, or about 45 mm).

In an example, the seal member 40 has a width of about 50-80 mm (e.g.,60-70 mm, or about 65 mm, or about 53 mm).

In an example, the seal member opening 46 has a height of about 15-35 mm(e.g., 20-30 mm, or about 25 mm, or about 30 mm).

In an example, the seal member opening 46 has a width of about 20-40 mm(e.g., 30-40 mm, or about 35 mm).

The mask system may include one or more cuffs 50 coupled to sideportions of the mask 10, as best shown in FIGS. 1-5 and 1-9. The cuffmay be a male cuff (i.e. protrude from the mask 10, or may be a femalecuff, i.e. be contained within the bounds of the mask 10). In theillustrated example, the cuff 50 is a male cuff. Each cuff 50 includes amain body 51 and a flange 54. A hollow portion 52 is formed through themain body 51 and the flange 54 to permit the passage of breathable gassupplied by an air delivery tube. As shown in FIGS. 1-1 and 1-10, theflange 54 is configured to sealing engage the cuff connecting surfaces28, 38 of the back panel 20 and the front panel 30, for example bygluing, heat forming or welding (e.g., radiofrequency, ultrasonic)

The cuff 50 may have a generally tubular shape, for example a shapehaving an elliptical cross section. Alternative shapes and crosssections may be used, such as circular, square, rectangle with roundedcorners, ovoid, etc.

The flange 54 may also aid in positioning the air delivery tube. Forexample, the air delivery tube may slide over the cuff 50 until the airdelivery tube reaches the flange 54 which may be arranged to indicatethat the air delivery tube is correctly positioned.

The cuff 50 may be constructed of a polymer. Preferably, the polymer maybe semi-rigid or rigid so as to ensure air delivered from the airdelivery tube to the mask 10 is not restricted. The cuff 50 may beconstructed of, for example, nylon, polypropylene, polycarbonate.

In an example, the cuff 50 has an internal width along its longest axisof about 15-25 mm (e.g., about 20 mm).

In an example, the cuff 50 has an internal width along its shortest axisof about 5-15 mm (e.g., about 8.5 mm).

In an example, the cuff 50 has a thickness of about 1-3 mm (e.g., about2.5 mm, or about 1.5 mm).

A single air delivery tube may be connected to one cuff 50, while theother cuff 50 is sealed with a plug (not shown). Alternatively, two airdelivery tubes may be connected, respectively, to the two cuffs 50.

Headgear may be attached to the cuffs 50. The headgear may be formed asconduits to deliver breathable gas to the cuffs 50.

A vent may be provided in one or both of the cuffs or connectingportions 50. The vent may comprise a series of holes adapted to flushexhausted gases (e.g., CO₂) from the mask 10. Preferably, the cuff issubstantially rigid or semi rigid in order to maintain patency of thevent holes and reduces vent noise.

The cuff may preferably be configured as a female cuff to reduce thesize of the mask 10, enable easier connection with a tube and permit thetube or connector (the connector adapted to connect to the female cuff)to have a release button so that attachment and detachment is performedby the tube or connector rather than the cuff.

The cuff(s) could be incorporated into the headgear (e.g. form a part ofa headgear rigidiser). The cuff(s) may also provide a connection pointwith a headgear or headgear connector.

2.0 Sealing Arrangement

In an example shown in FIGS. 2-1 and 2-2, a seal member 40-1 is coupledto a back panel 20-1 and both the seal member 40-1 and the back panel20-1 include an opening to receive the patient's nose. The front panelis removed in these views for illustration purposes.

The back panel 20-1 may form a soft contact surface to interface withthe patient's skin (e.g., fleece or Coolmax® finish). Thickened paddedsections may be formed in the back panel 20-1 around high pressureareas, such as the nasal bridge region and the top of lip region, toenhance comfort. Further, the back panel 20-1 may also include rigidsections to provide support and/or shape to the back panel.

Headgear 60, including a strap 62, may be connected to the back panel20-1. The headgear may be adjustable through a loop tab or otherconnecting structure and/or may be auto-adjusting through provision ofelasticity in the strap 62.

The seal member 40-1 is configured as a thin elastic member and may beformed, for example, of textile, a polymer (e.g., silicone,polyurethane), or a combination thereof through, e.g., lamination orovermolding. The thin elastic seal member 40-1 is arranged to conform tothe shape of the patient's face (e.g., nose). Forces exerted on the backpanel 20-1, and in turn on the seal member 40-1, by the headgear 60further cause the seal member 40-1 to conform to the shape of thepatient's nose and/or face. The seal member is also activated bypressure of the breathable gas in the chamber forming portion (orcavity), and preferably the seal member may have a high level offlexibility to enable the seal member to more readily respond to systempressure inside the mask. When positive pressure is applied within themask, there is a self sealing action of the seal member to engage andconform to the shape of the patient's nose to form a seal therewith.

The length seal member that is unsupported (i.e. does not have anunderlying layer of back panel or other material), allows the sealmember to move freely and flex more readily to conform to the shape ofthe patient's face.

In accordance with examples of the disclosed technology, the seal membermay be positioned on the mask through attachment to the back panel ormay be otherwise formed on the back panel or other suitable surface ofthe mask (or formed as part of the back panel or other portion of themask). The seal member may include a number of configurations, and whenemployed with the back panel, the seal member and the back panel may beindividually configured or together combined in a number of ways to formvarious structures or seal arrangements which interface with thepatient's face to seal therewith and ensure that breathable gas iseffectively delivered to the patient's airways.

For example, instead of a separate seal member, the seal member may beformed as part of the back panel: Further, support padding may beincluded in the mask to enhance comfort and/or to improve the quality ofthe seal around difficult areas to seal such as the crevices on thesides of the nose. Also, various parts of the mask may includerigidizing structures. In the following sections, several of suchconfigurations or arrangements are described. It will be understood thatany feature described in relation to one example, may be used orcombined with another feature in a different example.

2.1 Separate Seal Member

In the example shown in FIG. 3-1, a seal member 40-2 is coupled to aback panel 20-2. The seal member 40-2 may be welded or comolded with theback panel 20-2. As best shown in FIG. 3-1A, the seal member is flexibleso as to conform to the patient's face and/or nose. The seal memberincludes a first end portion 40-2(1) connected to the back panel and asecond end portion 40-2(2) to seal against the patient's face and/ornose. The seal member may be formed of silicone or polyurethane, forexample, and may further include a single or double wall configuration.

In a further example shown in FIG. 3-2 and in contrast to the sealmember 40-2, a seal member 40-3 has an S-like shape in cross-sectionhaving a first end portion 40-3(1) connected to the back panel 20-3 anda second end portion 40-3(2) positioned to seal against the patient'sface and/or nose. The S-like shape of the seal member 40-3 causes theseal member to function as a spring. Such spring action will tend tocause the seal member to exert a spring force against the patient'sface. The spring force may enable the seal member 40-3 to better conformto the curvature of the patient's face and/or nose, which may enhancethe quality of the seal and comfort to the patient by allowing thepressure force on the face to be more gradual.

The first end portion 40-3(1) may be thickened to increase support,whereas the second end portion 403-(2) may be thinned down to increaseflexibility of the seal member 40-3 which may enable to seal member tobetter conform to the curvature of the patient's face and/or nose.

2.2 Back Panel with Integral Seal Member

In an example, a seal member 40-4 may be formed as part of a back panel20-4, as shown in FIG. 4-1. The textile portion forming the seal member40-4 may be thinner than the back panel 20-4 to increase conformance tothe patient's facial features. Such an arrangement may reducemanufacturing complexity, cost, and may make the mask more visuallydesirable.

2.3 Raised Sealing Arrangement

Referring to FIGS. 5-1 to 5-8B, a cushion may include a raised (i.e.protruding) section which may enhance comfort and improve the sealagainst the patient's face (especially in hard to seal areas).

As shown in FIG. 5-1, a mask 10-1 includes a front panel 30, a backpanel 20-5 coupled to the front panel, a raised section 90 disposed onthe back panel 20-5, and a seal member 40-5 formed or positioned on theraised section 90. As best shown in FIG. 5-2, where the back panel 20-5is removed from the front panel 30, the raised section 90 includes acushion portion, padding or padding member 92 which may be formed offoam, for example. The foam may be silicone foam (e.g., a low density,low durometer and/or washable silicone foam). Other foams orcushion-providing material may also be used (e.g., polyurethane foam,open or closed celled foam, skinned or unskinned foam, gel, spacerfabric and/or pile material.

As illustrated in FIGS. 5-2A and 5-3, when the mask 10-1 is worn, theraised section 90 protrudes towards the patient's face and throughcompression of the padding 92 extends into hard-to-seal areas such asthe crevices on the sides of the nose. In other words, the seal member40-5 is better able to conform to curvatures on the patient's face asthe padding provides a light evenly distributed force on the seal member40-5. As such, the quality of the seal with the patient's face may beenhanced. Additionally, the padding 92 improves comfort to the patientas it provides a cushioning effect to pressure points (e.g., above thetop lip and at the nasal bridge). In a further alternative, the cushionportion or padding 92 may be shaped to match the contours of thepatient's face.

The padding 92 may be embodied in the mask 10-1 in various arrangements.In the example shown in FIGS. 5-3 and 5-4, the padding has a first endconnected to the back panel 20-5 and a second end connected to a firstend portion 40-5(1) of the seal member 40-5. A second end portion40-5(2) of the seal member 40-5 extends radially inwardly from thepadding 92.

In another example, a back panel may form an enclosure (or receivingcavity) to house the padding.

Particularly, as shown in FIG. 5-5, a back panel 20-6 includes an innerlayer 20-6(1) and an outer layer 20-6(2). The inner layer 20-6(1) may bea coated textile layer (e.g., textile with polyurethane coating) toprovide air tightness. The outer layer 20-6(2) may provide a soft outersurface to interface with the patient's skin. The outer layer 20-6(2)may part from the inner layer 20-6(1) to form a receiving portion 94-1(e.g., a concave or U-shaped formation). The receiving portion 94-1 andthe inner layer 20-6(1) together form a receiving cavity 95 whichreceives the padding 92. Further, a seal member 40-6 may have a firstend portion 40-6(1) connected to the receiving portion 94-1 and a secondend portion 40-6(2) extending radially inwardly from the receivingportion 94-1. The seal member 40-6 may be connected to the receivingportion 94-1 by injection molding, compression molding, gluing,ultrasonic welding or other techniques. The edges of the joins betweenthe inner layer 20-6(1) and an outer layer 20-6(2) may be rounded byultrasonic welding or another technique so as to maximize patientcomfort and overall visual appearance of the mask. The arrangement shownin FIG. 5-5 may be advantageous as the padding is enclosed and thereforemay remain cleaner; further, the overall device may appear neater andmore visually appealing and may also be simpler to manufacture.

In a further example shown in FIG. 5-6, a back panel 20-7 includes aninner layer 20-7(1) and an outer layer 20-7(2). The inner layer 20-7(1)and the outer layer 20-7(2) may have the same compositions describedabove with reference to the back panel 20-6. The outer layer 20-7(2)parts from the inner layer 20-7(1) to form a receiving portion 94-2(e.g., an L-shaped formation). Likewise, the inner layer 20-7(1) partsfrom the outer layer 20-7(2) to form a receiving portion 97-1 (e.g., anL-shaped formation). The receiving portions 94-2, 97-1 together form thereceiving cavity 95 which receives the padding 92.

The outer layer 20-7(2) may extend beyond cavity 95 to form a connectinglip 121. The inner layer 20-7(1) may have a connecting lip 122 that isjoined to the connecting lip 121 of the outer layer 20-7(2) to form amounting structure 124 for a seal member 40-7. The seal member 40-7includes a first end portion 40-7(1) which is connected to the mountingstructure. The first end portion 40-7(1) comprises a first leg 152, asecond leg 154 and a receiving space 155 therebetween. The receivingspace 155 is configured to receive the mounting structure 124 to securethe seal member 40-7 to the back panel 20-7. The first leg 152 may havea length that enables the first leg 152 to abut against the inner layer20-7(1) of the back panel 20-7, whereas the second leg 154 may have alength that is larger than the first leg 152 so that the second leg 154extends along the outer layer 20-7(2) of the back panel 20-7 asufficient distance to ensure that the seal member 40-7 is stablymounted to the back panel 20-7. This arrangement may be preferable sincethe foam is enclosed and thereby shielded or protected from dirt andother undesirable materials. The seal member 40-7 may be more securelyattached to the back panel 20-7 since a greater surface area is incontact with the back panel, in addition to having multiple planes ofcontact with the back panel 20-7 and the edges of the joins between theinner layer 20-6(1) and an outer layer 20-6(2) (e.g., the mountingstructure 124) may be utilized to attach the seal member 40-7 and thussupport a portion of seal member 40-7.

In another example, the seal member 40-7 may be configured and connectedto the back panel 20-7 in the same manner described above with referenceto the seal member 40-6 and the back panel 20-6.

In another example, the padding 92 is molded, glued or otherwiseconnected to a back panel 20-8, as shown in FIG. 5-7. The back panel20-8 forms a receiving portion 97-2 (e.g., an L-shaped formation). Thepadding 92 (e.g., silicone foam) is molded to the receiving portion 97-2such that an upper surface 92(1) and a first side surface 92(2) of thepadding 92 engage the back panel 20-8 and a lower surface 92(3) and asecond side surface 92(4) are exposed from the back panel 20-8. Thisarrangement may be advantageous as fewer materials are required (i.e. nofront panel) and the foam may contact the patient's face which may becomfortable for the patient to wear. Since the foam is exposed, it mayact as an end of life indicator (i.e. once the foam gets dirty it willserve as an indicator to the patient to get a new mask).

Referring to FIGS. 5-8A and 5-8B, the sealing arrangement may beconfigured to accommodate anthropometric variance in nose depth. Forinstance, the sealing arrangement may be configured to comfortably fitboth patients with nose bridges having a shallower depth as well as nosebridges having a larger depth. A patient having a shallower nose bridgedepth d1 is represented in FIG. 5-8A and a patient having a larger nosebridge depth d2 is represented in FIG. 5-8B. In other words, d1 issmaller than d2.

Padding 92 may be connected to a back panel 20-9. The padding 92 in theupper lip region may be thicker than the padding in the nasal bridgeregion, as shown in FIGS. 5-8C and 5-8D. That is, the nose bridge regionmay have little to no padding and a longer membrane as compared to theupper lip region. This is because the seal at the nose bridge region ispreferably a membrane or flap type seal, as this type of seal can morereadily accommodate varying anthropometrics. In addition, the membranetype seal may extend towards and connect directly or adjacent to thefront panel in order to maximize the space for the user's nose bridge.Preferably, at the sides of nose and upper lip region there is more foamand less membrane so as to allow a compression type seal (so that thefoam can compress into the crevices and creases particularly in thecorners of the nose to facilitate sealing in these areas). The foam mayalso be more comfortable in these regions. In another example, the foammay have the same depth around the perimeter of the seal portion to forma compression type seal all of the way around the patient's nose.

In the illustrated example of FIGS. 5-8A to 5-8D, A seal member 40-9 isfurther connected to the padding 92. The seal member 40-9 may have aU-shaped configuration at least in the nasal bridge region of thepatient's face. A first end portion 40-9(1) of the seal member 40-9 isconnected to the padding 92 and a second end portion 40-9(2) of the sealmember 40-9 is arranged to engage the patient's face. The first andsecond end portions 40-9(1), 40-9(2) generally form the legs of theU-shaped seal member 40-9. Such configuration may enable the seal member40-9 to extend to reach the face of a patient having a shallower nosedepth. Additionally, the U-shaped configuration allows the seal member40-9 to collapse and conform to the patient's face (i.e. the first andsecond end portions 40-9(1) and 40-9(2) are moved closer to one another)when positioned on a patient having a larger nose bridge depth. The sealmember may have a preformed curvature such that the collapse iscontrolled.

The padding 92 functions to evenly distribute pressure against the sealmember 40-9, thereby improving comfort to the patient. The U-shaped sealmember 40-9 may be limited to regions of the seal member proximate thenose bridge region as this region tends to vary significantly frompatient to patient. The seal member 40-9 may be substantially flat inother regions of the seal member that would be generally positioned ator near the patient's upper lip (FIGS. 5-8C and 5-8D), as this regiontends to have less anthropometric variation.

2.4 Rigidizing Structures

In accordance with the disclosed technology, rigidizing structures maybe incorporated into a mask to provide, for example, support, shape,form and/or strength to the mask, as well as to prevent distortion ofthe mask. In addition, a rigid element may interconnect two or moreother rigid components to ease manufacturing and stabilize and positionthe rigid components relative to one another. The rigidizer may form asupport band. The rigidizer may be flat and able to bend to a curvatureor may be preformed in a curved manner. The rigidizer may be constructedand arranged to support a portion of the mask, as the mask itself maynot be able to support its own weight or may not be able to support anapplication of force (e.g. tube drag force).

Referring to FIG. 6-1, a mask includes a rigidizer frame 70 layered ontop of the back panel 20-2. The rigidizer frame 70 includes sideportions 70(2) which extend along the sides of the mask adjacent thecuffs. In an example, the side portions 70(2) may be connected to thecuffs 50. An interconnecting portion 70(1) extends across the upper lipregion of the patient and bridges or interconnects the side portions70(2). The interconnecting portion 70(1) may cause the back panel 20-2and/or the seal member 40-2 to more stably engage the patient's fate inthe upper lip region. This may enhance the seal with the patient's face.Further, by extending to both sides of the mask, the rigidizer frame 70resists distortion of the mask which may result from over-pulling of thestraps.

Referring to FIGS. 7-1 to 7-4, a rigidizer frame 72 is shown positionedon the back panel 20-2. The rigidizer frame 72 includes cheek portions72(2) configured to rest adjacent the patient's cheeks, side of noseportions 72(3) extending from the cheek portions 72(2) partially acrossthe patient's nose in the direction of the nasal bridge, and aninterconnecting portion 72(1) extending across the upper lip region ofthe patient bridging or interconnecting the cheek portions 72(2). Theinterconnecting portion 72(1) functions similarly to the interconnectingportion 70(1) described above.

A gap may tend to form between the back panel 20-2 (and/or the sealmember 40-2) and the patient's face in the portions extending betweenthe patient's nasal bridge and cheeks. The side of nose portions 72(3)shown on the left and right sides of the mask, provide support and shapeto the back panel 20-2 and seal member 40-2 in this region. The side ofnose portions 72(3) may have a curvature 72(3)a similar to that of thepatient's face (from the patient's cheeks to nasal bridge) which mayforce the back panel 20-2 and/or seal member 40-2 to conform to thecurvature of the patient's face to reduce or prevent leakage. Slots72(4) may be formed as part of the rigidizer frame 72 and may receiveheadgear straps or may be configured to connector to cuffs for example.

Turning to FIG. 8-1, in an example, a rigidizer frame 74 may extend froma cuff 50-1. The rigidizer from 74 may be a separate member connected tothe cuff 50-1 or may be integrally formed with the cuff. In anotherexample shown in FIG. 8-2, a rigidizer frame 76 may extend from a cuff50-2 and additionally include an interconnecting portion 76(1) layeredagainst the front panel 30 and bridging or interconnecting the cuffs50-2 to provide shape, form and resist distortion which may result fromover-pulling of the straps.

In another example, the first end portion 40-3(1) of the seal member40-3 in FIG. 3-2 may be thickened to act as a rigidizer frame.

The rigidizer frames described above may be overmolded, glued or weldedfor example to the mask panels prior to assembly. They may also formseparate removable components that are inserted into the mask after themask is assembled.

The rigidizer frames may be rigid or semi-rigid. For example, therigidizer frames may be made of flexible semi-rigid plastics such aspolypropylene, nylon, polycarbonate, etc. Further, the masks may berigidized through lamination of high-density foams with the textilepanels (e.g., front and back panels). These laminated structures canalso be thermoformed to add shape and strength (e.g., by varying thethickness of the laminated structure and/or by adding specific designfeatures such as ribbing).

Rigidizing or strengthening of the mask can also be achieved through useof non-elastic textiles (e.g., in the front and back panels). Thenon-elastic textiles may form the mask or may be strategically added tothe mask to achieve a desired rigidizing or strengthening effect. Suchnon-elastic textiles may prevent over-stretching in certain directions(e.g., across the upper lip region) which may cause distortion of themask, or more particularly, the front panel, the back panel and/or theseal member.

In an example, the rigidizer frames may be used limitedly so as topreserve the lightweight, soft and comfortable feel of the textile mask.Further, the use of rigidizer frames over sensitive areas such as thenasal bridge and upper lip areas may be avoided to improve patientcomfort by reducing pressure loading in these areas.

In a further alternative, the rigidizer frames may be positioned tooverlay the nose bridge, upper lip or other sensitive regions; however,they may be constructed and arranged to avoid contact with the patient'ssensitive facial regions. That is, the rigidizer frame may be elevated,raised or curved away from the patient's face, thereby avoidingcontacting sensitive regions while still functioning to stabilize and/orstrengthen the mask and/or support the shape of the mask.

2.5 Mask Configured to Fit Wide Range of Nose Sizes

As shown in FIG. 9, the width d5 of the opening in the back panel 20-1is designed to accommodate a majority of nose sizes so as to fit amajority of the user population with one mask size. The width d5 is wideenough to accommodate the width d4 of a wide nose while the seal member40-1 extends radially inwardly enough from the back panel 20-1 such thatthe width d1 of the seal member 40-1 opening in its unstretched state insufficient to create a good seal against a narrow nose (having a widthd2).

Further, the seal membrane is preferably made of a thin high-stretchmember (e.g., textile, silicone, or polyurethane membrane) so as tostretch (to a width d3) to receive the width d4 of a wide nose withoutocclusion.

The back panel 20-1 functions to hold the seal member 40-1 in shape andto assist pulling the seal member 40-1 down onto the patient's face.

2.6 Multi-Layer Seal Member

Referring to FIG. 10-1, a mask system 100 may include a mask 110 havinga multi-layer seal member 140. The mask system 100 includes headgear 160and an air delivery tube to supply breathable gas to the mask 110. Theheadgear includes a strap 162 connected to the mask 110 (e.g., the backpanel and/or front panel). The strap 162 may be continuous or mayinclude two straps having an adjustable connection. In eitherarrangement, the strap 162 has a single vector V1 (The vector for onlyone side of the mask is shown).

The mask 110 includes a back panel 120 having the seal member 140connected thereto. The mask may also include a front panel (not shown).The mask forms a cavity to receive the patient's nose to deliver thebreathable gas to the patient's airways. The seal member 140 is arrangedto seal against the patient's face and/or nose when the patient's noseis received in the cavity. The seal member 140 includes a base layer 141connected to the back panel 120, an interfacing layer 145 to contact thepatient's face, and a cushioning layer or cushion portion 143 disposedbetween the base layer 141 and the interfacing layer 145, as shown inFIG. 10-2.

Referring to FIGS. 11-1 and 11-2, the base layer 141 has a generallytriangular shape; however, other shapes may be used. An opening 141(1)is formed in the base layer 141 to receive the patient's nose. Theopening 141(1) may also have a generally triangular shape, althoughother shapes may be used. The opening 141(1) is intended to frame thepatient's nose.

The width d1 of the opening 141(1) is made smaller than theaverage/standard anthropometric measurement to require the base layer141 to be stretched (by tension from the strap 162) in order to receivethe patient's nose. The height d2 of the opening 141(1) is sized suchthat the upper portion of the base layer 141 rests on the lower end ofthe nasal bridge, as shown in FIG. 11-3, which prevents the mask fromobstructing the patient's vision. Width d1 may be about 25-60 mm inlength, for example about 30 mm-45 mm, for example about 40 mm. Heightd2 may be about 15-50 mm in length, for example about 20 mm-40 mm, forexample about 30 mm.

Upon receiving a tensile force from the strap 162, the seal member 140is pulled into sealing engagement with the patient's face. The baselayer 141, in particular, functions to cause the seal member 140 toachieve a seal in the upper lip and nasal bridge regions. As shown inFIGS. 11-3 and 11-4, an upper lip sealing area 141 a spans the upper lipof the patient and extends to the corners of the nose. A nasal bridgesealing area 141 b is located at a lower end of the nasal bridge.

The base layer 141 may be made from a high stretch, air impermeablematerial such as thermoplastic polyurethane (TPU) film. The base layer141 may be also be made from a dense stretchable fabric such as NylonLycra. Other suitable materials may also be used. The stretchability andelasticity of the base layer 141 cause the base layer 141 to pressagainst the patient's face when the tensile force is applied. Thisaction pushes the interfacing layer 145 against the patient's face toachieve a seal in the upper lip sealing area 141 a and the nasal bridgesealing area 141 b.

The cushioning layer 143 preferably has a perimeter geometry that isidentical to that of the base layer 141. The cushioning layer 143 has araised (or thicker) profile and is intended to provide cushioning to theseal member 140. The opening 143(1) in the cushioning layer 143 has awidth d3 and a height d4 that correspond generally to the width d1 andthe height d2 of the opening 141(1) in the base layer 141.

As the seal member 140 is pulled in tension across the nasal bridge, theportion of the seal member spanning the lateral parts of the nose tendsto elevate from the patient's face forming gaps 177 (or potential leakpath) between the seal member 140 and the patient's face (e.g., thelateral parts of the nose), as illustrated in FIG. 12-3. The cushioninglayer 143 functions to provide “mass” against the lateral parts of thenose to fill the gaps 177 while also providing padding over the nasalbridge, as shown in FIG. 12-4.

The cushioning layer 143 may include foam, spacer fabric, plush fabrics,pile fabrics, fibers and/or gel which may be laminated to theinterfacing layer 145. The addition of padding to the seal member 140may assist with sealing against the patient's face (e.g., by fillinggaps along lateral parts of the nose). Padding may also improve comfortto the patient, especially in the nasal bridge region, as well as addingaesthetic value to the mask. Preferable material properties of thecushioning layer 143 include the ability to conform to the patient'sface as well as having the ability to add bulk/mass to the seal member140.

The interfacing layer 145 is arranged to contact the patient's face. Theinterfacing layer 145 includes an opening 145(1) to receive thepatient's nose, as shown in FIGS. 13-1 and 13-2. The opening 145(1) hasa generally inverted T shape and includes a central cutout 145(1)ahaving a generally triangular shape, an upper slit 145(1)b extendingvertically from an upper portion of the central cutout, and lower slits145(1)c, 145(1)d extending from left and right lower sides of thecentral cutout 145(1)a. It is noted that the opening 145(1) may haveother shapes.

The width d5 of the opening 145(1) may be larger than the width d1 ofthe opening 141(1) in the base layer 141. This arrangement may assist inpressing the cushion into sealing engagement with the corners of thepatient's nose. That is, the base layer may provide support andadditional force to press and stretch into the crevices positioned atthe sides of the patient's nose. Width d5 may be about 1-5 mm less thanwidth d1. Height d6 of the opening 145(1) may be equal to or less thanand the height d2 of the opening 141(1) in the base layer 141.

The opening 145(1) in the interfacing layer 145 forms two flaps 176,178. As the patient's nose enters the cavity formed in the mask 110, theflaps 176, 178 fold and conform to the lateral parts of the patient'snose to achieve a seal. As shown in FIGS. 13-3 and 13-4, each flap 176,178 respectively seals against the patient's face in a side of nosesealing area 176 a, 178 a along the lateral parts of the nose. Thetensile force applied by the strap 162 causes the interfacing layer 145to be pulled in tension across the upper lip and the nasal bridge toachieve a seal in the upper lip sealing area 141 a and the nasal bridgesealing area 141 b.

The interfacing layer 145 may be made from a comforting textile.Preferable material properties for the interfacing layer materialinclude minimal stretchability, air impermeability, conformability tothe patient's face, and/or the ability to provide a comforting interfacewith the patient's face. The minimal stretch of the interfacing layer145 provides a limiting wall that anchors the seal around the nostrils.

The interfacing layer 145 preferably includes silicone which may aid theseal member 140 in achieving a robust seal against the patient's face.Silicone provides an appropriate level of friction and compliance thatis advantageous in improving the seal over the lateral parts of thenose. Use of silicone may also enhance overall mask stability.Alternative materials include thermoplastic elastomers (TPE),polyurethane (PU) coated textiles, non-coated textiles.

The base layer 141, cushioning layer 143 and interfacing layer 145 maybe joined by radiofrequency welding, ultrasonic welding, stitching, seamtape, glue, heat stake, overmolding or other air tight sealing methods.Alternatively, the join may not be air tight and instead may permitventing through the seam.

In another example, the base layer 141 and the interfacing layer 145 maybe used without the cushioning layer 143 to form a seal member 140-1, asshown in FIG. 14.

The interfacing layer 145 may be joined to the base layer 141 bystitching or thermoforming, for example. The base layer 141 shape framesthe patient's nose and provides a limiting wall about which theinterfacing layer 145 folds.

2.7 Continuous Surface Seal Member

Referring to FIG. 15-1, a mask system 200 includes a mask 210 having acontinuous surface that seals over the patient's nose. Particularly, themask 210 includes a back panel 220 having an upper panel 220 a and alower panel 220 b. An opening 222(1) is formed between the upper panel220 a and the lower panel 220 b. The opening 222(1) receives thepatient's nose as it is inserted into the cavity formed in the mask 210.The mask 210 may include a front panel (not shown).

The upper and lower panels 220 a, 220 b may be formed from a coatedtextile (e.g. a PU coated textile, over-molded textile). Preferably, theupper and lower panels 220, 220 b form a thin air tight fabric.

The upper panel 220 a has two folds or darts 222 (only one is shown)which cause the upper panel to form a curved portion extending aroundthe opening 222(1) having a peak 221 that protrudes outwardly away fromthe mask 210, that is, the upper panel 220 a forms a curved portionadapted to engage the patient's nose. As shown in FIG. 15-2, the mask210 is positioned on the patient's face by engaging the peak 221 againstthe patient's nose. As the patient's nose enters the mask, it forces theupper panel 220 a to extend into the cavity of the mask. Since the upperpanel 220 a is constructed to protrude outwardly as described above,once the patient's nose causes the upper panel 220 a to turn inside out,the same forces causing the upper panel 220 a to protrude outwardly nowurge the upper panel around the patient's face, thereby enhancingconformance with the patient's facial features.

Referring to FIG. 15-3, the upper panel 220 a may be connected to thelower panel 220 b by joining the tabs 220 a(1), 220 a(2) of the upperpanel with the tabs 220 b(1), 220 b(2) of the lower panel and stitchingthe tabs along the seam lines 224, 225 and 226, 227. The seam line 228may represent a seam for joining the upper panel 220 a to another maskpart (e.g., a front panel): Likewise, the seam line 229 may represent aseam for joining the lower panel 220 b to another mask part (e.g., afront panel).

The upper panel 220 a includes an upper seal portion 246 which sealsacross the patient's nose, as shown in FIG. 15-7. The upper seal portion246 extends from a portion of the nose between the nasal bridge and thetop of the nose clown across the flaring parts of the nose (i.e.,external nares) to the corners of the nose. As shown in FIG. 15-6, thelower panel 220 b includes a lower seal portion 248 which seals acrossthe patient's upper lip. Upon receiving tension from the strap 162, thelower seal portion 248 seals along the upper lip region. The upper sealportion then conforms to the patient's nose as it enters the mask. Asthe breathable gas is delivered, the upper seal portion 246 and thelower seal portion 248 may be further engaged with the patient's face.

Turning to FIG. 15-4, the upper panel includes a lower boundary 242extending between the tab 220 a(1) and the tab 220 a(2). The width d1between the tab 220 a(1) and the tab 220 a(2) corresponds to the excessportion of the upper panel 220 a formed around the opening 222(1) shownin FIG. 15-1. This excess portion is used to seal across the patient'snose, as best shown in FIG. 15-7. The width d1 should be undersized(e.g., with respect to average/standard anthropometric measurement) sothat the upper panel 220 a (e.g., the upper seal portion 246) has to bestretched around the patient's nose. Width d1 may be about 50-90 mm, forexample about 60-75 mm, for example about 70 mm. This arrangementfunctions to reduce the likelihood of folds and creases in the upperseal portion which tend to create leak paths. Therefore, the materialforming the upper panel may have some flexibility or stretchcharacteristic.

The lower boundary 242 may have a radius of curvature r1. The radius ofcurvature r1 determines the location of the lower boundary 242 withrespect to the tip of the patient's nose (i.e. nose tip), as shown inFIG. 15-5. In an example, the radius r1 may be about 60-90 mm. Forexample, radius r1 may be about 65-80 mm. For example, radius r1 may beabout 75 mm.

Referring to FIG. 15-6, the lower panel 220 b includes an upper boundary244 extending between the tab 220 b(1) and the tab 220 b(2). The widthd2 between the tab 220 b(1) and the tab 220 b(2) corresponds to thewidth of the opening 222(1). Width d2 may be about 20-50 mm, for exampleabout 30-45 mm, for example about 38 mm. The width d2 may be undersized(e.g., by 0.5-2.5 mm) from the average/standard anthropometricmeasurement in order to cause the lower panel 220 b to be stretched toreceive the patient's nose. Upper boundary 244 is adapted to form alower perimeter surface of the sealing portion and is shaped to conformto the patient's septum and/or philtrum.

The seams 225, 227 provide foundation, stiffness and/or shape to theupper seal portion 246. The seams 225, 227 may also be angled to affectthe angle and/or orientation of the portion of the upper panel 220 aextending around the opening 222(1).

3.0 Mask Assembly

Referring to FIGS. 16-1 to 16-5, textile (e.g., fabric) mask parts(e.g., panels, seal member, cuffs) may be welded (e.g., radiofrequency,ultrasonic) together to form a mask. In addition to welding, mask partsmay be glued, stitched and/or overmolded to join the parts. In order todeliver respiratory therapy, the textile panels should be airtight.Further, the stitching and welds should have minimal leakage.Accordingly, textiles having a tight weave and/or a coated textile(e.g., a polyurethane or silicone coated textile) may be used.

Referring to FIGS. 16-1 and 16-2, the upper 22 and lower 24 flanges ofthe back panel 20 and the upper 32 and lower 34 flanges of the frontpanel 30 may be clamped together and welded to connect the parts. Thecuffs 50 may be positioned between the back panel 20 and the front panel30 and welded in place.

The back panel 20 and the front panel 30 are preferably made of textileand may be thermoformed to obtain their shape. The seal member 40 may bewelded or thermoformed onto the back panel 20.

The front panel 30 and the back panel 20 may be locally rigidized orsoftened (e.g., by altering the weight of the textile, laminatingdifferent density foams to the textile panels, and/or includingsemi-rigid frames).

As shown in FIGS. 16-3 and 16-5, the two cuffs 50 may be inserted intoeach end of the mask to allow connection with two air delivery tubes.

In an example, the front panel 30 and the back panel 20 may be weldedwhile positioned inside out and then reversed after completion ofwelding to hide the weld seam.

Although several examples described herein refer to a front panel and aback panel, it will be understood that masks in accordance with thedisclosed technology may be constructed from any number of textilepanels. For example, the mask 310 shown in FIGS. 17-1 to 17-4 isconstructed on five textile panels. First 322 and second 324 panelsextend over a back portion of the mask. The first panel has a sealmember 340 formed thereon. The seal member 340 has an opening 346 toreceive the patient's nose. Third 332, fourth 334, and fifth 336 panelsare connected to one another and extend over a front portion of themask. The third panel 332 connects to the first panel 322 and the fifthpanel 336 connects to the second panel 324, as shown in FIG. 17-2. Inthe illustrated example, the panels 322, 324, 332, 334, 336 are stitchedtogether. Some or all of the panels may have different materialproperties (e.g. panel 322 may be soft and comfortable as it may providemost of the interface with the patient's face). Panel 322 may be, forexample, cloth, terry toweling, felt, or other soft fabric. Panel 324may be a moisture wicking fabric as it is positioned proximate to thepatient's nose and may absorb humidified exhaled air. Panel 334 may bemade from a relatively stiff fabric as this panel may need to supportthe shape of the mask (e.g. a spacer fabric or reinforced woven). Panels332 and 336 may be relatively flexible as these panels may need toconform to different patient's anthropometry (e.g. linen).

Cuffs 50 may extend from sides of the mask 310 and straps 362 may beconnected to the mask, as shown in FIGS. 17-3 and 17-4.

In another example shown in FIG. 17-5, a back panel 420, a bottom panel480, and a front panel 430 may be joined (e.g., by stitching) to form amask. The back panel 420 includes a seal member 440 thereon having anopening 446. The back panel 420 further includes an upper tab 422 and alower tab 426.

The bottom panel 480 may be positioned proximate to the patient's upperlip on the non-face contacting side of the mask. The bottom panel 480includes an upper tab 484 and a lower tab 486. The front panel 430 maybe positioned proximate the patient's nose bridge region on the non-facecontacting side of the mask. The front panel includes an upper tab 432and a lower tab 434. The front panel 430 may also include darts 435 orseams located on either side of a central, nose bridge engaging portion.The darts 435 may be sewn (e.g., along stitch lines 435(1) in a fold(e.g., along center line 435(2)) in order to give the front panel andhence the mask a three dimensional shape.

According to the present example, the darts 435 are first formed in thefront panel 430. The dart center line 435(2) can be marked with dartstitch lines 435(1) positioned on both sides of the dart center line.The dart stitch line 435(1) is folded over the dart center line 435(2)and a stitch or other connection means is formed along the dart stitchlines to create a fold in the front panel. These folds create a threedimensional shape to bend the textile of the front panel so that thefront panel is shaped to conform to curvature of face.

After the darts 435 have been formed in the front panel 430, the frontpanel can be stitched or otherwise connected to the bottom panel 480 byjoining the upper tab 484 of the bottom panel 480 to the lower tab 434of the front panel 430. The front 430 and bottom 480 panels may then bestitched or otherwise connected to the back panel. For example, theupper tab 422 of the back panel 420 may be joined to the upper tab 432of the front panel 430, and the lower tab 426 of the back panel 420 maybe joined to the lower tab 486 of the bottom panel 480.

4.0 Headgear

Headgear is used to effectively position the mask on the patient's faceduring treatment. The headgear may be adjustable to enable a single masksystem to fit a wide range of people. Additionally, patients often feelthe need to adjust their headgear on a daily basis.

Headgear adjustments can be broken down in to macro adjustments andmicro adjustments. Macro adjustments refer to the larger adjustmentsthat relate to the overall size of the mask (e.g., small size, mediumsize, large size). These adjustments are usually performed only once(e.g., during first time setup). Alternatively, the mask systems may beoffered in 2 to 3 different size groups to eliminate the need for macroadjustment.

After the initial setup, only smaller (micro) adjustments are needed inresponse to leaks and/or face/neck movements for example. Microadjustments refer to the smaller adjustments that might occur on a dailybasis. These adjustments typically may be made to reduce leaks,accommodate for pressure sores on the patient's face, to adjust for neckmovement in the standing vs. lying positions and/or to adjust for straplocation on the patient's head which tends to vary from night to night.

The provision of elasticity in the headgear straps may cause theheadgear to make micro adjustments automatically. Elastic straps hold acertain degree of “tolerance” for certain movements, such as neckflexing and head turning. In other words, the use of elastic straps mayaccount for enough anthropometric variance within a certain size groupthat the headgear may be self-fitting and not require any fineadjustments.

In an example shown in FIG. 18-1, a mask system 500 includes a maskhaving headgear 560 connected thereto. The headgear 560 includes asingle strap (e.g., an elastic strap). The bottom strap is configured toextend along the patient's face (e.g., along the jaw bone) below theears and around a rear portion of the patient's neck. A cuff 550 isconnected to a side of the mask and connects to an air delivery tube580. A tube anchor or anchor member 592 is attached to the strap 562 andreceives the tube 580. The tube anchor is configured to provide a tubemanagement system. The tube anchor may facilitate use of a textile maskas the tube anchor may absorb some of the weight of the tube. Since thetextile mask is light (as compared to other masks such as plasticmasks), the weight of the tube may adversely affect the mask. Inaddition, a single strap (as shown) is preferred as it is lessobtrusive; however, this arrangement provides less support to thetextile mask as compared to some other mask systems. Hence, the weightof the tube may tend to pull the textile mask away from the patient'sface. The tube anchor may absorb part of the tube's weight and henceenable the textile mask to seal.

The provision of a single strap 562 keeps to a minimum the number ofstraps and connection points for the headgear. This arrangement reducesclutter and obstruction of the patient's vision, and also enhances easeof use. The strap 562 has a single vector V1 which exerts a tensileforce on the mask as referred to in the examples described above.

Turning to FIGS. 18-2 and 18-3, a headgear 660 is shown. The headgearhas a single side connection point on each side of the mask 510. Thesingle side connection point is advantageous because it minimizes visualbulk and is easier for the patient to attach (as compared to multipleside attachment points). The headgear 660 includes a side strap 668having a lower portion 668(1) connected to the mask 510 and an upperportion 668(2) extending upwardly from the lower portion. The lowerportion 668(1) is adapted to be positioned along the patient's cheek orbelow the patient's cheek bone, in order to avoid obstructing thepatient's eyes. The upper portion 668(2) is adapted to be positionedalong the sides of the patient's face, extending between the patient'seyes and ears. An elastic bottom strap 662 is connected to the lowerportion 668(1) of the side strap 668 and is configured to extend alongthe patient's face (e.g. along the jaw bone) below the ears and around arear portion of the patient's neck. The elasticity in the bottom strap662 adjusts automatically to accommodate for neck movements such aslowering or raising the head.

The upper portion 668(2) of the side strap 668 extends from the lowerportion 668(1) of the side strap 668 upwardly at an angle. The sidestrap 668 may be rigidized to provide an upward vector to the mask 510.The side strap 668 may be shaped to conform to the shape of thepatient's head or may be flexible enough to conform to the shape of thepatient's head. In the illustrated example, the side strap has a firstvector V1 corresponding to the lower portion 668(1) and a second vectorV2 corresponding to the upper portion 668(2).

The headgear 660 further includes an elastic back strap 664 connected tothe upper portion 668(2) of the side strap 668 and extending downwardlyaround the patient's head. The back strap 664 may abut against or bejoined to the bottom strap 662 to form a double strap portion at a rearportion of the patient's head. Further, a top strap 667 is connected toleft and right upper portions 668(2) of the side straps 668 and extendsover the top of the patient's head. The top strap 667 may apply anupward force to the side straps 668 thereby providing an upward vectorto the mask.

An air delivery tube 680 may be connected to a cuff 550 via a tubeconnection 682 disposed at an end of the air delivery tube 680. The cuff550 may comprise vent holes 55(1) to exhaust expired gases. The cuff 550may include 1-100 vent holes, for example about 10-30 vent holes, forexample about 20-50 vent holes, for example about 3-20 vent holes, forexample about 40-70 vent holes, for example about 50-80 vent holes. Asshown in FIG. 18-3, the air delivery tube 680 may comprise two channelsor lumens 680(1), 680(2). Alternatively, the air delivery tube 680 maycomprise a single lumen in order to increase manufacturing efficiencyand reduce impedance (as compared to a double lumen tube).

Referring to FIGS. 18-4A and 18-4B, headgear 760 is shown. The headgear760 includes an elastic bottom strap 762 extending along the patient'sface (e.g., along the jaw bone) below the ears and around a rear portionof the patient's neck and connecting to side portions of the mask (e.g.,back panel 20-1). As mentioned above, the elastic bottom strap 762 canadjust automatically to accommodate for neck movements such as loweringor raising the head which may cause the length of the bottom strap 762to change.

In an alternative example, the straps may not be elastic or may be acombination of elastic and non-elastic, thus incorporating an adjustmentmechanism (e.g. hook and loop material). Hence, the strap may have macroadjustment through the adjustment mechanism and micro adjustment throughthe elastic portion of the strap.

Side straps 768 connect to side portions of the mask (e.g., back panel20-1). In another example, the side straps may connect to the bottomstrap 762, or even partially to both the mask and the bottom strap. Theside straps 768 have a curve 769 or bend which allows the side straps768 to extend in a manner that avoids obstruction to the patient'svision. The side straps 768 may include a first portion on one side ofthe curve 769 and a second portion on the other side of the curve, andthe second portion may extend relatively more upwardly than the firstportion. (i.e. following substantially along patient's cheek bones thentracing up between patient's eye and ear). The side straps 768 may berigidized to add support and/or an upward vector to the cushion. Sideand top straps may be optional i.e. the patient can selectively attachthese straps if required.

A top strap 767 is connected to respective side straps 768 and extendsover the top of the patient's head. The top strap 767 may apply anupward force to the side straps 768 thereby providing the upward vectorto the mask (which may assist with preventing the tube weight frompulling the mask away from the patient's face).

Further, a back strap is connected to respective side straps 768 andextends around the patient's head (e.g., around the occiput).

Turning to FIG. 18-5, headgear having a three-point connection to a maskis shown. The headgear includes an elastic bottom strap 862 extendingalong the patient's face (e.g., along the jaw bone) below the ears andaround a rear portion of the patient's neck and connecting to sideportions of the mask (e.g., back panel 20-1), as mentioned above. Anupper connector 869 provides the third point of connection with the mask510 and extends from an upper portion of the mask to connect to a frontstrap 866.

The upper connector 869 may be relatively light and flexible and may beconstructed of a plastic such as nylon, polypropylene or polycarbonate.Alternatively, the upper connector 869 may be constructed of a fabric ortextile. The upper connector 869 may also be constructed of acombination of materials such as a fabric with a plastic rigidizer. Theupper connector 869 could be elastic or non-elastic. Ideally, the upperconnector 869 is thin to avoid the patient's eyes and line of sight.Preferably, the upper connector 869 may be padded or selectively paddedto avoid marking the patient's forehead or region of the face.

A crown strap 864 forms a loop intended to encircle the crown the of thepatient's head. A lower extent of the crown strap 864 may be joined withthe bottom strap 862 to provide form to the headgear 860 when it is notworn, and further to more reliably locate the headgear on the patient'shead.

A front strap 866 extends from an upper portion of the crown strap 864and connects to the upper connector 869. For example, the upperconnector 869 may have a slot 869(1) through which the front strap 866is looped. The front strap 866 further includes an attachment portion(e.g., hook or loop material) configured to fold back onto and attach tothe front strap 866 (which for example may be configured with the matingportion of the hook or loop material).

Referring to FIGS. 18-6A to 18-7B, a mask system includes a mask 910connected to a bottom strap 962. As best shown in FIGS. 18-7A and 18-7B,one end of the mask 910 includes a cushion tab 910(1) which may beconnected directly (e.g., sewn) to the bottom strap 962. A cuff 950 ispositioned adjacent the cushion tab 910(1) and configured to connect toan air delivery tube. The other side of the mask 910 may include a,connector (e.g., a raised L-shaped tab) configured to be received in aconnecting member 963 (e.g., an opening) formed in the bottom strap 962.

The bottom strap 962 (i.e., a front portion of the bottom strap) iselastic to provide for micro adjustments. The bottom strap 962 may havea rear portion 964 including an adjustable connection that provides formacro adjustments. The rear portion 964 may be elastic, non-elastic orhave a different (e.g., lower) elasticity as compared to the bottomstrap 962. In an example, a connector 965 including a slot 965(1) isconnected to a first side of the bottom strap 962. The rear portion 964is connected to the second side of the bottom strap 962 and is loopedthrough the slot 965(1). The rear portion 964 further includes anattachment portion 964(1) (e.g., hook or loop material) to allow thelength of the rear portion 964 to be adjusted.

In another example, only one side of the bottom strap 962 may be elasticand the other side may have an adjustable connection, as shown in FIG.18-6C.

In another example shown in FIGS. 18-6D and 18-6E, a rear portion 1074of the bottom strap 962 may include a first portion 1074(1) connected toa first side of the bottom strap 962 and a second portion 1074(2)connected to a second side of the bottom strap 962. The first portion1074(1) may include an attachment portion 1074(1)a having holes 1076formed therein to receive plugs 1078 formed on an attachment portion1074(2)a of the second portion 1074(2).

As shown in FIG. 18-6E, the first and second portions 1074(1), 1074(2)may have visual clues and/or markers corresponding to headgear sizes. Inan example, the attachment portion 1074(1)a may have an edge 1077configured to be aligned with a visual marker (e.g., a line, groove,embossment, etc.) that is associated with a visual clue 1075 (e.g., theletters S, M, L, or other indicators of small, medium, large) of thesize of the headgear. For instance, when the edge 1077 is aligned withthe visual marker 1079 associated with (or positioned next to) thevisual clue 1075 “L,” the patient will understand that the headgear hasbeen adjusted to its “large” size.

As shown in FIG. 18-6B, a tube anchor 992 may be attached to the bottomstrap 962 to hold an air delivery tube. The tube anchor 992 wraps aroundthe tube to maintain the tube in position relative to the headgear. Thetube anchor 992 could be a loop made from, for example, elastic, plasticor other materials. The loop may be stitched, welded, molded orotherwise formed into a continuous loop. The loop may be selectivelyopenable or may be stretchable to receive the tube.

It may be preferable to position the tube anchor 992 at the rear of thepatient's head. In this location, the tube may be positionedperpendicular to a flow generator and thus have less tube drag. Inaddition, if the tube anchor is positioned at the nape of the patient'sneck, it may be more comfortable for the patient and may be less likelyto dislodge as it is protected in the curved portion of the patient'sneck underneath the occiput.

5.0 Swivel Elbow

In an example, a mask system may include an air delivery conduit 1180that is rotatable with respect to the mask 1110. The air deliveryconduit may be connected to the mask via an elbow 1118. The elbow has afirst leg and a second leg having an angle (e.g., a 90° angle)therebetween. The first leg of the elbow 1118 is connected to aconnector portion 1180(1) of the air delivery conduit 1180. The secondleg of the elbow 1118 is connected to an annular elbow connection 1115of the mask 1110. The elbow 1118 and the annular elbow connection 1115have a mating arrangement that allows the elbow to swivel with respectto the annular connection 1115. A suitable elbow is described in U.S.Provisional Patent Application 61/648,807, filed 18 May 2012, which isincorporated herein by reference in its entirety

Annular elbow connection 1115 may be connected or form part of aninternal mask rigidized section (e.g. rigidized frame) so as to avoidexerting force on the textile portion of the mask. The rigidizer mayalso be connected to the cuffs and the headgear therefore transferringthe weight of the tube and forces applied to the tube to the headgear.This may assist in stabilizing the mask in position. Alternatively, theannular elbow connection 1115 may be attached to an unsupported sectionof the textile mask thereby allowing the mask to flex and move freelywhen a force is applied to the tube. That is, because the textile isflexible, it can readily adapt its shape depending on the forces appliedto it via the tube, and hence may decouple tube drag forces from thesealing portion of the mask.

6.0 Tube Management

As the patient moves during the night, forces (e.g., drag) exerted onthe air delivery tube (or tube) may be transferred to the mask in amanner that disrupts the seal with the patient's face. Thus minimizingtube drag may ensure that a good seal is maintained and in turn enhancethe effectiveness of treatment.

In an example, tube drag forces may be minimized or prevented byanchoring the tube on the patient's body (e.g., at the back of the headon the headgear) so as to support part of the weight of the tube. Thisarrangement leaves only a short portion of the tube to hang between themask and the anchor point which substantially reduces the amount of tubeweight that is supported by the mask.

To facilitate routing the tube behind the patient's head to connect witha tube anchor attached to the headgear, the tube may be connected to themask at a side portion of the mask. This arrangement reduces theapparent bulk (size) of the mask system making it less obtrusive andmore aesthetically appealing. The side connection also provides theshortest distance from the mask to the anchor point, thereby minimizingobstruction to the patient caused by the size of the mask system as wellas minimizing the risk of tube drag.

In the illustrated example of FIGS. 19-1 to 19-5, to facilitatesupporting the tube with an anchor attached to the headgear, it ispreferable to route the tube along the same line as the bottom strap(e.g., along the jaw bone). By this arrangement, it is likely that thepatient's head will rest on the tube. To enhance comfort to a patienthaving part of their body lying over the tube, a tube having a flatprofile may be used to provide a flat or even surface for the patient torest against. A flat tube routed over a headgear strap may reduce thevisual bulk of covering and disguising the tube against the strap and/orcreate a simpler design by streamlining the components.

Alternatively, in another example, the tube may run freely down besidethe mouth and away from the mask (flexing in the major and/or minor tubeaxis directions in relation to the tube cross section).

In any case, a more compliant or flexible tube may allow for thegreatest flexibility in tube orientation.

Referring to FIGS. 19-2 to 19-5, a mask system utilizing a tube anchorattached to the headgear is shown. The mask system includes a back panel20-1 having a rigidizer frame 1072 layered thereon. The rigidizer frameincludes an interconnecting portion 1072(1) and cheek portions 1072(2)attached to opposite ends of the interconnecting portion.

A bottom strap 1062 is connected to side portions of the mask (e.g., theback panel 20-1 or rigidizer frame 1072) and extends along the patient'sface (e.g., along the jaw bone) below the ears and around a rear portionof the patient's neck. One side of the mask may include a connector 1065(e.g., attached to the back panel 20-1) having a slot 1065(1) formedtherein. The bottom strap 1062 may be routed through the slot 1065(1)and folded back onto itself to adjust tension in the bottom strap 1062.The bottom strap 1062 may include an attachment portion 1062(1) (e.g.,hook or loop material) to secure to the bottom strap.

A cuff 1050 is attached to a side portion of the mask (e.g., the backpanel 20-1 or rigidizer frame 1072) and provides a connection point forthe air delivery tube 1080. In the illustrated example, the mask systemmay include two air delivery tubes 1080 connected to the cuff 1050 in aside-by-side arrangement.

As best shown in FIG. 19-5, a tube anchor 1092 is attached to the bottomstrap 1062 at (or towards) the back (or a rear) of the patient's head(e.g., below the occiput, adjacent the nape, or below the ear). In theillustrated example, the tube anchor 1092 forms a loop to receive theair delivery tube therein. The air delivery tubes 1080 are feed throughthe tube anchor 1092 which aids in supporting the weight of the airdelivery tubes 1080. It may be preferred to position the tube connectionat the back of the patient's head to increase the patient's range ofmotion and prevent the tube being pulled to the side.

In the illustrated example, the mask (e.g., the back panel 20-1 andfront panel (removed for illustration purposes) is made of textile.Further, the mask is held on the patient's face with only a single strap1062. As the textile mask of the illustrated example may be less rigidthat other mask systems (e.g.; those having plastic frames), provisionof the tube anchor 1092 to aid in supporting the weight of the airdelivery tube may enhance performance of the textile mask system.

It will be understood that the tube anchor may be positioned at otherlocations along the bottom strap 1062. Further, it may be possible toprovide the tube anchor on other headgear straps such as those shown anddescribed in FIGS. 18-2 to 18-5 for example.

6.1 Air Delivery Tube

Referring to FIGS. 21-1A to 21-2, an air delivery tube having a supportstructure provided thereon is shown. The support structure may provideshape, form and occlusion resistance to the tube. Tubes, some havingsupport structures, are described in PCT Application PCT/AU2012/000667,filed Jun. 8, 2012, which is incorporated herein by reference in itsentirety. The tubes described in PCT/AU2012/000667 may be implementedinto any of the examples described in this application.

In the example shown in FIG. 21-1A to 21-2, a tube having a tube wall1230 and a support structure 1240 provided to the tube wall 1230 isshown. The tube has a capsule or race track-shaped cross-section;although other shapes may be used. (e.g., oval, rectangular havingrounded edges, a structure having four sides (i.e. two opposing sidesthat are substantially longer than the other two opposing sides). Thetube wall 1230 may comprise a flexible tape. The support structure 1240wraps around the tube wall 1230 in the manner of a helix. The supportstructure 1240 (e.g., ribs) is relatively wide as compared to theexposed tube wall 1230 sections. A tube cuff 1260 may be provided atends of the tube to connect to a cuff disposed on the mask and/or a flowgenerator.

The relatively wide support structure 1240 may be desirable for tube insections close to the patient's face, since the wider support structureprovides fewer strips of material which may mark the patient's face. Itmay also be more comfortable for the patient to lie on a tube with aflatter profile as compared to a round profile.

For example, in the arrangement shown in FIGS. 19-1 to 19-5, the tubearrangement shown in FIG. 21-1A may extend only from the mask around thepatient's neck to the tube anchor 1092; thus, this section of the tubeis not required to bend in a severe manner and may be suitable for thissection. The width of the support structure 1240 may be reduced in tubesections further away from the patient's face to increase flexibility ofthe tube.

Turning to FIGS. 21-3A and 21-3B, a tube wall 1230-1 encloses twochannels 1232, 1234 which are configured to allow passage of breathablegas therein. A support structure 1240-1 (e.g., ribs) is provided to thetube wall 1230-1. A tube cuff 1260-1 may engage the support structure1240-1 and extend therefrom for connection to a cuff 50-3 which isattached to a mask 1210. The tube cuff 1260-1 and the cuff 50-3 may forma dovetail connection for example, or any other suitable connection.Tube wall 1230-1 may be an optional component. Tube wall 1230-1 may be,for example, fabric or a plastic extrusion. The tube cuff 1260-1 may beover-molded onto the tube wall 1230-1.

Referring to FIG. 21-4, an air delivery tube 1380 includes first andsecond tube covers 1321, 1331 that cooperate to form the tube. The tubecovers 1321, 1331 may include an inner layer of a film laminate (e.g.,polyurethane or medical grade film) and an outer layer of a textile orfabric (e.g., synthetic or specified fabric). A rigid, or semi-rigidsupport substrate 1340 may be inserted into the tube to provide crushresistance and form. In the illustrated example, the support substrate1340 includes a central base 1340(1) and upper and lower generallycurved arms 1340(2), 1340(3) extending from respective sides of thebase.

Referring to FIGS. 21-5A to 21-5D, a tube cover 1421, 1431 in sheet formmay have a support structure 1440 formed thereon (e.g., co-extruded,printed, overmolded, heat formed). Each tube cover 1421, 1431 may beplaced in a tool 1450 which thermoformed the tube covers 1421, 1431along with the support structure 1440 into a half tube shape. The twotube covers 1421, 1431 are then welded together, a shown in FIG. 21-5C.After welding, flanges 1421(1), 1431(1) of the joined tube covers 1421,1431 may be ultrasonically cut thereby leaving a rounded end 1450, asshown in FIG. 21-5D.

Turning to FIGS. 21-6A to 21-6C, an air delivery tube 1580 includes atube cover 1521 that may have a rigid or semi-rigid support substrate1540 inserted therein. In the illustrated example, the support substrate1540 includes a central base 1540(1) and upper and lower generallycurved arms 1540(2), 1540(3) extending from respective sides of thebase.

In another example, shown in FIGS. 21-7A and 21-7B, a tube sheet 1620may be provided with a support structure 1640 to form an integrated onepiece composite self-supporting textile conduit. The tube sheet 1620 ispreferably a fabric that is air-resistant or completely air-tight (e.g.,may include film laminate or air-tight layer). The support structure1640 may comprise a rib structure including one or more rib formations.The tube sheet 1620 may be inserted into a relatively flat tool and thesupport structure 1640 may be molded in a pattern on top of the tubesheet 1620. In another example, the support structure maybe overmoldedonto the tube sheet 1620.

The tube sheet 1620 may include fasteners 1650 attached to end portionsof the tube sheet such that the tube sheet may be rolled into a tube andthe fasteners 1650 connected to retain the tube shape as an air deliverytube. It is noted that the ends of the tube sheet may be joined by othermeans.

Similar to the tube 1580 shown in FIGS. 21-6A to 21-6C, a tube 1780 isshown in FIGS. 21-8A and 21-8B. A tube cover 1721 may have a rigid orsemi-rigid support substrate 1740 inserted therein. In the illustratedexample, the support substrate 1740 includes a central base 1740(1) andupper and lower generally curved arms 1740(2), 1740(3) extending fromrespective sides of the base. The arms extending from one side of thecentral base 1740(1) may be staggered with respect to the arms extendingfrom the other side of the central base 1740(1).

In another example, as shown in FIG. 21-9, a support substrate 1840includes a series of body portions 1842 connected by alternating sets oflateral links 1843 and central links 1844. The alternating links1843,1844 are designed to provide structural support to the supportsubstrate 1840 in both the horizontal and vertical directions, while atthe same time providing flexibility.

In another example, shown in FIG. 21-10, a support substrate 2040includes a pair of body portions 2012, 2014 connected by windingconnector 2042. The winding connector 2042 includes a series of flatlegs 2042(1) extending along a bottom of the support substrate 2040 in agenerally flat manner. The flat legs 2042(1) may extend at an angle. Aseries of vertical legs 2042(2) connect to end portions of respectiveflat legs and extend generally in a vertically manner so as to provide aspace through a central portion of the winding connector 2042 that willfunction as an air passageway. A series of connecting legs 2042(3) mayextend at an angle to interconnect the vertical legs 2042(2) with anadjacent flat leg 2042(1).

In yet another example shown in FIGS. 21-12A and 21-12B, a supportsubstrate 2140 includes two support members 2142 connected by a firstwave member 2143 and a second wave member 2144. The first and secondwave members have a matching or opposite mirror image sinusoidal shape(i.e. the wave members 2143, 2144 are out of phase such that the peak ofone of the wave members is aligned with a trough of the other wavemember) and are connected to each support member 2142 at opposite pointsso as to provide a space between the wave members 2143, 2144 that willfunction as an air passageway. The wave members 2143, 2144 are describedas having an identical shape; however, one skilled in the art wouldrecognize that the wave members could have different shapes while stillmanaging to provide structural support, form and/or crush resistance.Any suitable number of wave members could also be connected between thesupport members 2142. Intermediate support members 2142 could also beprovided. Preferably, wave members 2143, 2144 may be curved about thelongitudinal axis of the tube (at the apex of the curves of the waves)to form the rounded edges of the tube i.e. to create capsule crosssection.

A plurality of struts 2145 may extend between and connect the first 2143and second 2144 wave members to provide structural support.

Referring to FIG. 21-11, this example shows a similar technology to thatshown in FIGS. 21-12A and 21-12B; however, the first wave member 2241and a second wave member 2243 are in phase i.e. the peaks and troughs ofeach wave are aligned. In addition, struts 2245 may be provided at thepeaks and troughs of each wave instead of being positioned intermediatethe peaks and troughs of each wave as shown in FIGS. 21-12A and 21-12B.

Referring to FIG. 21-13, a support substrate 2340 includes a series ofbody portions 2346 connected by links 2352. The support substrate 2340is similar to the support substrate 1840 in FIG. 21-9 and is similarlydesigned to provide support while allowing flexibility. In contrast tothe support substrate 1840, the support substrate 2340 may includeopenings or cutouts in the body portions 2346 which may reduce weightand/or provide increased flexibility. End portions 2344 may be connectedto cuffs or connectors 2342 which may be configured to connect to a cuffof a cushion and/or a flow generator.

While the technology has been described in connection with severalexamples, it is to be understood that the technology is not to belimited to the disclosed examples, but on the contrary, is intended tocover various modifications and equivalent arrangements included withinthe spirit and scope of the technology. Also, the various examplesdescribed above may be implemented in conjunction with other examples,e.g., one or more aspects of one example may be combined with one ormore aspects of another example to realize yet other examples. Further,each independent feature or component of any given assembly mayconstitute an additional example. In addition, while the technology hasparticular application to patients who suffer from OSA, it is to beappreciated that patients who suffer from other illnesses (e.g.,congestive heart failure, diabetes, morbid obesity, stroke, bariatricsurgery, etc.) can derive benefit from the above teachings. Moreover,the above teachings have applicability with patients and non-patientsalike in non-medical applications.

1. A mask system for delivering pressurized breathable gas to a patient,comprising: a chamber forming portion including: a front and a backpanel at least partially delimiting a cavity adapted to receive a noseof a patient, the back panel including opening formed therein throughwhich the patient's nose is received into the cavity; a seal memberformed as part of or coupled to at least one of the front or back paneland adapted to sealingly engage the patient's face, wherein at least oneof the front or the back panel comprises a textile and the seal membercomprises a polymer.
 2. The mask system according to claim 1, whereinthe front panel is welded to the back panel.
 3. The mask systemaccording to claim 2, wherein the front and back panels each have aconcave shape.
 4. The mask system according to claim 2, wherein sealmember is positioned between the front panel and the back panel.
 5. Themask system according to claim 2, wherein the back panel comprises alower engaging surface and the lower engaging surface is shaped toconform to a septum and/or philtrum of the patient.
 6. The mask systemaccording to claim 1, wherein the seal member comprises a polymer havinga Shore A hardness in the range of 5-20.
 7. The mask system according toclaim 1, further comprising a cuff connected to a side portion of thechamber forming portion, the cuff being adapted to receive an airdelivery tube.
 8. The mask system according to claim 1, wherein the backpanel and the seal member are integrally formed in one piece.
 9. Themask system according to claim 1, wherein the seal member has an “S”shape in cross-section having a first end coupled to the chamber formingportion and a second end configured to engage the patient's face. 10.The mask system according to claim 9, wherein the seal member applies aspring force against the patient's face.
 11. The mask system accordingto claim 1, further comprising a padding member interconnecting the backpanel and the seal member, wherein the padding member is configured tocompress thereby urging the seal member into conformance with thepatient's face.
 12. The mask system according to claim 11, wherein thepadding member comprises foam.
 13. The mask system according to claim 1,further comprising a rigidizer frame coupled to the chamber formingportion to provide structural support.
 14. The mask system according toclaim 13, wherein the rigidizer frame is positioned on the first paneland is configured to extend across the patient's upper lip.
 15. The masksystem according to claim 13, wherein the rigidizer frame includes atleast one sides of nose portion having a curvature configured to conformto a region of the patient's face between the patient's cheeks and thepatient's nasal bridge.
 16. The mask system according to claim 1,wherein the seal member includes a base layer and an interfacing layercoupled to the base layer and configured to sealingly engage thepatient's face.
 17. The mask system according to claim 16, wherein theseal member further includes a cushioning layer provided between thebase layer and the interfacing layer.
 18. The mask system according toclaim 1, further comprising headgear including a bottom strap coupled tothe chamber forming portion and configured to extend from a first sideof the chamber forming portion around a rear portion of the patient'sneck to a second side of the chamber forming portion. 19.-33. (canceled)34. A mask system for delivering pressurized breathable gas to apatient, comprising: a chamber forming portion including: a back panelat least partially delimiting a cavity adapted to receive a patient'snose, the back panel including an upper panel coupled to a lower panelsuch that an opening is formed between the upper panel and the lowerpanel, the opening configured such that the patient's nose is receivedinto the cavity through the opening, wherein the upper panel has anupper seal portion configured to seal against the patient's externalnares, and the lower panel has a lower seal portion configured to sealagainst the patient's upper lip. 35.-54. (canceled)
 55. Headgear forsupporting a patient interface on a patient's face, the patientinterface arranged to be positioned adjacent the patient's nose insealing communication with at least one of the patient's airways, theheadgear consisting essentially of: only a single strap, the strap beingcoupled to the patient interface and extending from a first portion ofthe patient interface to a second portion of the patient interface,wherein the headgear is configured to provide primary support to thepatient interface for supporting the patient interface on the patient'sface. 56.-71. (canceled)